**Before the**

**Federal Communications Commission**

**Washington, D.C. 20554**

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| In the matter of                 | *  | ET Docket No. 03-92          |
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| Biotronik, Inc .                 | ** |                              |
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| Request for Waiver of the        | *  |                              |
| Frequency Monitoring             | *) |                              |
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| Requirements for the Medical     |    |                              |
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| Communications Service Rules     | ** |                              |
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**ORDER**

**Adopted: February 18, 2004 Released: February 26, 2004**

By the Commission:

# INTRODUCTION

1.  By this Order, we grant a request for waiver filed by Biotronik,
    Inc., authorizing it to build and market its Philos DR-T medical
    implant device, as originally configured,[^1] as well as other
    similar devices, to operate in the Medical Implant Communications
    Service (MICS) band, 402-405MHz. The Philos DR-T is a low-power
    implanted transmitter that operates in conjunction with a cardiac
    pacemaker to facilitate data (non-voice) communication from the
    device to a doctor. The data is transmitted from the implanted
    device to a radio receiver that is contained inside a specialized
    cellular telephone located in close proximity to the patient. The
    data is then relayed via the cellular telephone to a data collection
    point for later review by a doctor. Biotronik also holds a
    certification for implantable cardiac defibrillators[^2], and for
    implantable cardioverter defibrilators[^3], with the same
    monitoring/communications function, and additional cardiac implant
    devices await certification. The devices are designed to communicate
    data in the event of certain changes in the patient's condition or
    through manual activation, and also at regular intervals for
    periodic monitoring of the patient's condition. The last function of
    these devices is at variance with the MICS rules, and will be
    temporarily permitted by way of the three-year waiver granted
    herein.

2.  This waiver request has been opposed by Medtronic, Inc. (Medtronic),
    the developer of another medical implant device that complies fully
    with the MICS rules. Medtronic earlier opposed the grant of
    equipment authorization for the Philos DR-T, on the basis that the
    operation of the device violates the MICS rules.

# BACKGROUND

3.  In 1999, the Commission established the MICS service to support the
    diagnostic and/or therapeutic functions associated with implanted
    medical devices to enable individuals and medical practitioners to
    utilize potential life-saving medical technology without causing
    interference to other users of the spectrum.[^4] The Commission
    determined that the 402-405 MHz band is particularly well suited for
    this service, due to the signal propagation characteristics in the
    human body, the relative dearth of other users of the band, the
    compatibility of the MICS service with the incumbent users of the
    band, and its use internationally for this purpose.[^5] To avoid
    harming other users of the frequency band, MICS was provided a
    secondary allocation. The 402-405 MHz band was, and remains,
    allocated on a primary basis to Federal Government uses, including
    Meteorological Aids Service (Metaids), the Meteorological Satellite
    Service, and the Earth Exploration Satellite Service.[^6] We adopted
    technical rules specifically designed to protect these incumbent
    Federal services and to ensure compatibility among multiple MICS
    devices and users.[^7] These rules establish 10 channels of 300 kHz
    each for this service within the allotted bandwidth (47 C.F.R.
    § 95.628(c), (d)), provide for frequency sharing and cooperation in
    the selection and use of channels (47 C.F.R. § 95.1211), and
    establish specific guidelines for frequency monitoring prior to
    transmission by implant programmer/control transmitters (47 C.F.R. §
    95.625(a)).[^8] Given these protections, the National
    Telecommunications and Information Administration (NTIA),
    representing the incumbent Federal user entitled to exclusive use of
    this band, interposed no objection to this allocation.[^9]

4.  On, February 12, 2003, the Commission found that the Philos DR-T,
    lacking a listen-before-talk function, does not comply with the
    Commission's rules when it sends regular, pre-programmed
    transmissions, although it operates within the rules when activated
    manually or by changes in the patient's condition or in the device
    itself.[^10] At the same time, the Commission also denied
    Biotronik's alternative request for waiver of the rules to permit
    this pre-programmed transmission function in the Philos DR-T.[^11]
    In that Order, the Commission did, however, affirm OET's
    determination that the non-pre-programmed functions of the device
    comport with the MICS rules, and denied Medtronic's request that we
    fully rescind the equipment authorization that had been granted to
    Biotronik.[^12]

5.  In making this determination to deny Biotronik's initial waiver
    request, we found that while the impact of pre-programmed
    transmissions by the DR-T would be *de minimis*, Biotronik had not
    attempted to demonstrate it could not just as effectively serve
    patient needs with a device that complies with our rules or that
    there is a hardship or burden in complying with the rules.[^13] We
    also noted that the MICS spectrum is primarily allocated for Federal
    use and that the NTIA, which represents the federal government's
    spectrum interests, advised us that it believed a waiver of the
    rules would not be appropriate for the DR-T.[^14]

# PLEADINGS

6.  Biotronik here has filed a new waiver request, reiterating its
    request for a permanent waiver of the MICS rules for its Philos
    DR-T, and also for "like devices in the future, which have the
    periodic scheduled transmission feature."[^15] The current Philos
    DR-T operates at an output power of 6.27 nanowatts (compared to the
    25 µW maximum for MICS), and transmits in bursts of 80 milliseconds,
    repeated seven times within an hour, generally between 2:00 and 3:00
    in the morning, and most typically in the bedroom of a patient's
    residence while he or she is asleep. Biotronik supplemented its
    initial request by specifying that it seeks waiver only for cardiac
    implant devices, and only for transmissions in bursts of up to 280
    milliseconds \[repeated ten times per day\] at a maximum output
    power of 100 nanowatts, on the same 40 kHz channel on which the
    Philos DR-T operates.[^16] Biotronik argues that good cause exists
    for, and the public interest would be served by, a grant of this
    waiver request. Biotronik contends that requiring compliance with
    the frequency monitoring requirements of the MICS rules would impose
    an undue hardship on Biotronik and disserve cardiac patients, as it
    would take at least two years to redesign and manufacture new
    devices, and they would be larger and more expensive and have
    shorter battery life, with no corresponding benefit to patients**.**
    It insists that its devices can operate without a reasonable risk of
    causing or receiving harmful interference, and that the redundancy
    of its messaging eliminates any possibility that important
    information will fail to be collected, even in the unlikely event
    that the device receives harmful interference. Accordingly, it
    argues, the underlying purpose of the rules, and the public
    interest, would be served by grant of the waiver. It further asserts
    that it has resolved the explicit concerns that led the Commission
    to deny its waiver request in the *Philos MO&O*, *supra*, *i.e.*, it
    has now demonstrated a need for the waiver and NTIA no longer
    opposes its operation, and that its waiver request therefore should
    be granted.

7.  Medtronic counters by noting initially that the Commission has
    already denied Biotronik a waiver for the Philos DR-T, and a second
    request should not be countenanced. It reiterates our earlier
    finding of noncompliance, and asserts that the device does pose a
    risk of interference by not complying with the MICS transmission
    protocols. Medtronic further asserts that grant of this waiver will
    undermine the spectrum sharing premise on which the MICS service is
    based, open the floodgates to additional noncompliant devices, and
    thus reduce or obviate the utility of this spectrum for highly
    valuable compliant therapeutic devices. Medtronic also insists that
    there is no need for a waiver, asserting that Biotronik could alter
    its device to comply with the Commission's rules, claiming that
    adequate alternative spectrum not subject to the MICS sharing
    regimen is available for such devices, and that frequency monitoring
    technology exists for use in the MICS band. Medtronic also contends
    that there is no proof the Philos DR-T is not susceptible to
    interference, as such a critical device needs to be, and that the
    international adoption of frequency monitoring rules for such
    medical implant devices as well as NTIA's earlier rejection of
    Biotronik's waiver request on the basis of possible interference to
    the devices from radiosondes confirm this concern. Medtronic urges
    that at the least, the Commission limit the duration of any waiver
    granted to Biotronik. Finally, Medtronic charges that Biotronik has
    marketed devices that fail to comply with the now-settled
    requirements for the Philos DR-T, and cannot avail itself of the
    equitable remedy of a waiver.

# discussion

8.  We find that, on balance, Biotronik has now submitted sufficient
    justification for the grant of a waiver of the MICS rules to permit
    periodic scheduled transmissions by its Philos DR-T and similar
    cardiac implant devices. There is good cause for granting this
    waiver, and it is in the public interest to do so.[^17] To deny the
    waiver would frustrate the underlying purpose of the rule, and
    Biotronik, and the patients it will serve have no reasonable
    alternative at this time.[^18] The periodic/automatic transmissions
    of the DR-T and similar devices that we authorize hereby are used to
    assist doctors in identifying trends in a cardiac patient's
    condition in order to refine medical diagnosis and treatment of the
    patient[^19] -- advancing the Commission's fundamental purpose in
    establishing the MICS service.[^20] These devices are compact and
    use well-established, simple technology that is reliable and
    preserves battery life., and they operate at microscopic power
    levels and durations that are highly unlikely to cause interference
    in the MICS service or to other users of that band -- a fundamental
    condition of the MICS service. They are also unlikely to receive
    harmful interference that would obstruct their function in the
    present environment -- another important element of MICS service.
    The MICS service is secondary in its band, and the primary user of
    the band has consented to the operation of this device, as further
    discussed below. Finally, the significant medical value of these
    devices as presently constituted for current cardiac patients is a
    compelling factor in our consideration.

9.  While Medtronic argues that listen-before-talk technology is most
    consistent with sound spectrum management, and while Biotronik is
    working on devices that will observe the frequency monitoring
    protocol,[^21] the devices considered herein are available now and
    in the immediate future to provide life-saving medical care.[^22] As
    Medtronic argues, "\[g\]rant of a waiver requires that 'strict
    compliance with the rules \[would be\] inconsistent with the public
    interest.'"[^23] Biotronik has now demonstrated that revising its
    devices to fully comply with the MICS rules would not only delay
    their utilization by doctors for their patients, but would increase
    the size, complexity, and cost of the devices while reducing their
    battery life.[^24] Additionally, contrary to Medtonic's assertion,
    we cannot find that there is suitable alternative spectrum in which
    Biotronik can operate such devices, as further discussed below.

10. Many of Medtronic's points reiterate arguments it made in contending
    that the Philos DR-T violates the MICS rules, and those points will
    not be extensively addressed here. We have already found that the
    DR-T can initiate transmission by manual activation or in response
    to changes in a patient's condition without prior frequency
    monitoring, consistent with the MICS rules.[^25] We have also
    already found that the pre-programmed function of the Philos DR-T
    does not meet the MICS rules, as Medtronics emphasizes here. That is
    what necessitates consideration of this waiver.

11. Biotronik is not barred from this waiver request by our previous
    denial of its initial waiver request. Medtronic correctly notes that
    "\[t\]he FCC routinely dismisses pleadings that merely repeat
    rejected arguments \[citations omitted\]."[^26] However, in this
    case Biotronik does not merely repeat its earlier arguments, but
    offers new information and arguments, specifically directed to the
    failings of its earlier request that the Commission explicitly noted
    in the *Philos MO&O*, *supra*, and we find this new material both
    pertinent and persuasive. As is further discussed below, Biotronik
    has now demonstrated that it cannot effectively serve patient needs
    with a fully compliant MICS device or a device that operates on
    other frequencies at the present time or in the near future.
    Moreover, the NTIA, after further evaluating the function of the
    device, has removed its objection. Medtronic has offered no case or
    principle which suggests we cannot revisit this issue in the context
    of a new waiver request with our judgment informed by the additional
    information and argument now proffered by Biotronik.

12. The potential for the subject devices to cause harmful interference
    to other MICS devices or to receive harmful interference is
    negligible. An extensive study filed by Medtronic which purports to
    demonstrate the interference potential of the Philos DR-T[^27] is
    unavailing for several reasons. We observe that these devices
    operate extremely infrequently, about one half second a day, such
    that the possibility that two devices will be operating
    simultaneously in close proximity is extremely small. Further, we
    observe Medtronic analyzes several scenarios where it claims
    interference will occur. In two scenarios, Medtronic describes
    increased risk of interference to a Biotronik device because it uses
    such a weak signal. However, we observe that a Biotronik device
    repeats its transmissions to increase the likelihood that the signal
    will get through. In another scenario, Medtronic claims that the
    required distance separation to avoid interference to its devices
    under the current rules is approximately 12 meters, but the required
    separation from a Biotronik device would increase to approximately
    160 meters if the waiver were granted. We note that for this
    analysis Medtronic assumed the power of the Medtronic device would
    be reduced to the same level as proposed by Biotronik. Such an
    analysis is not relevant because Medtronic is nowhere required to
    reduce the power of its devices, and it can overcome the
    interference purported in its analysis simply by continuing to
    operate at the higher power levels permitted under the rules. While
    we must be cognizant of the possibility of harmful effects to the
    MICS service from the proliferation of devices that could experience
    increased interference, as argued by Medtronic, such a result does
    not appear likely from the DR-T and functionally similar devices.
    The power, frequency and duration of transmissions are all
    miniscule. We also note that this device was designed for and will
    virtually always be used in settings away from a clinical facility
    and during the middle of the night, and thus away from and other
    times than other potentially affected medical implant devices. This
    does not suggest the proliferation of potentially harmful signals
    that would conflict with anticipated MICS service, as feared by
    Medtronic.

13. The likelihood of the subject devices receiving interference that
    would compromise its function also appears negligible. This is very
    lightly used spectrum, which is one of the bases of its desirability
    for this function. The repetition of the signal virtually eliminates
    the possibility that the data will fail to be communicated. The
    proximity of the receive device to the transmitter and the location
    of these devices far from potential interference sources when
    transmitting (generally, a residential bedroom), make any occasion
    of interference highly unlikely. NTIA has withdrawn its initial
    objection (see below), and its continued caution regarding the
    presence of radiosondes is not intended to and does not persuade us
    that they present an interference potential sufficient to compromise
    the operation of the subject devices. The requirement for frequency
    monitoring in the MICS rules and adopted internationally, cited by
    Medtronic as a caution, do not contemplate the type of operation
    presented by the these devices, and thus do not, *per se*, argue
    effectively that harmful interference will occur in the absence of a
    frequency monitoring capability.

14. While Medtronic contends that the Philos DR-T (and, by extension,
    the related devices) could operate on non-MICS spectrum, we have
    already found the 402-405 MHz band most suitable for low-power human
    implant devices,[^28] and there does not appear to be suitable
    alternative spectrum for the very low power therapeutic devices. The
    existence of a few other medical transmit devices that operate at
    other frequencies on an unlicensed basis does not undercut this
    conclusion. While there is other spectrum in which unlicensed
    devices can operate, the spectrum specifically suggested by
    Medtronic[^29] is sufficiently congested to pose a danger that the
    very low powered transmissions of the Philos DR-T and the other
    similar Biotronik cardiac implants would not be clearly received.
    Moreover, the subject devices would have no interference protection
    from the plethora of other operating devices. The only devices
    specifically referenced by Medtronic are devices (with transmitters)
    that function, respectively, during a trip through the digestive
    tract and during a 5-7 day placement in the esophagus. These
    transmitters would appear to operate only over the course of several
    hours or a few days. The short-term function of these devices is not
    comparable to the long-term operation of the subject devices. In
    addition, the devices transmit to receivers worn on the body, as is
    practical with such short-term examinations. We also note that
    requiring the subject Biotronik devices to operate on frequencies
    outside the MICS would compromise their usefulness worldwide.

15. While it may be possible to alter the design of the Philos DR-T and
    other devices to function in conjunction with a
    controller/transmitter, as urged by Medtronic, it is now apparent
    that such a change would unnecessarily complicate the function and
    increase the size of a relatively small and simple device, with no
    apparent benefit to patients. Additionally, we now understand that
    such changes would delay the availability of this significant
    therapeutic device for thousands of patients.

16. On behalf of the Federal users that have the primary allocation in
    the MICS band, NTIA has now agreed to the grant of this waiver for
    use of the Philos DR-T and the current line of Biotronik's cardiac
    implant devices and future like devices with a pre-programmed
    periodic transmission function on the MICS spectrum.[^30] NTIA
    requests that the waiver specifically acknowledge that interference
    from radiosondes is a very real possibility and that medical
    professionals using these devices in those geographic areas of the
    United States where radiosondes are used be specifically advised of
    the schedules of local radiosondes, and we shall so condition this
    waiver.

17. Medtronic fails to persuade us that Biotronik has violated our
    marketing and sales rules and thus should be barred from the grant
    of the subject waiver. While Medtronic asserts that Biotronik has
    marketed its noncompliant Philos DR-T and has sold cardiac implant
    devices for which it holds experimental licenses (the Belos DR-T and
    Belos VR-T[^31]), in violation of the experimental licensing rules,
    [^32] it fails to substantiate those claims. Biotronik's devices are
    featured on the Biotronik web site and were included in a medical
    journal, but that is not *per se* inappropriate given the
    international nature of the business, and the web site clearly
    disclaims their sale in the U.S. Moreover, the device does have the
    potential to be operated in compliance with our rules. In
    conjunction with its application for the experimental license for
    the Belos devices, Biotronik has already demonstrated its compliance
    with the marketing restrictions.[^33] Neither does Biotronik's
    announcement of the Food and Drug Administration's approval of the
    Belos devices, *per se*, violate our rules. Although its
    announcement of the "commercial availability" of those devices in
    that press release is troubling, such a possible transgression of
    our rules is properly the subject of possible enforcement action.
    Similarly, if Biotronik is failing to observe the experimental
    license limitations for market studies by failing to inform users of
    its experimentally authorized defibrillators of the nature of their
    license, that issue, too, is best adjudged in an enforcement action.
    As for the Philos DR-T, Biotronik asserts that it has ceased
    implantation of the device since the Commission's decision in the
    *Philos MO&O*, *supra*, and Medtronic fails to controvert that
    assertion or otherwise substantiate the sale of any nonconforming
    device.

18. It is important to stress that we do not intend with this action to
    undermine the MICS service with this waiver, and this waiver is not
    "tantamount to a rule change," as charged by Medtronic.[^34] At the
    same time, we recognize that this waiver request and our action
    herein may presage a need or a reasonable desire for additional
    medical implant devices in this band that would operate at variance
    with the current MICS rules. For the present, however, we are
    excepting a specific device and a very narrow range of similar
    devices of which we expect there to be a limited number, and only
    for a limited period of time. Accordingly, we will grant this waiver
    for a period of three years. Additionally, we will condition the
    continued implantation of the devices covered by this waiver on
    their non-interference with other MICS devices. Should a pattern of
    interference develop that is traceable to devices operating pursuant
    to this waiver, we will rescind the waiver to prevent the
    implantation of additional devices.[^35]

19. This period of time should provide adequate window for the
    successful manufacture and utilization of the subject devices, and
    also a desirable opportunity to assess both the efficacy of this
    device and its individual and cumulative effect on the MICS service,
    without presenting a measurable threat to that service. Also, during
    this period, advances in technology may improve the operability and
    availability of listen-before-talk implantable devices, obviating
    the need for a waiver for future devices. On the other hand, our
    experience with the devices authorized by this waiver, as well as
    the progression of medical implant technology over the next few
    years, may indicate that the current MICS rules will not adequately
    accommodate appropriate medical implant devices. We will follow this
    matter closely, and if it becomes apparent that the MICS rules need
    revisiting to more widely accommodate these or other additional
    types of devices, we will promptly initiate a rulemaking proceeding,
    whether on our own motion or in response to a request by any party.
    The waiver granted herein, is also subject to the outcome of any
    such rulemaking proceeding.

    **V. ORDERING CLAUSE**

20. Accordingly, pursuant to Section 1.925 of the Commission's rules (47
    C.F.R. § 1.925), Biotronik, Inc.'s petition for waiver of the MICS
    rules IS GRANTED for the manufacture and use of the Philos DR-T
    implantable cardiac pacemaker and other implanted cardiac devices,
    as described in this Order, subject to the following conditions:

    This waiver applies to implanted cardiac devices only.

    This waiver is limited to devices whose communication function is
    limited to non-emergency communications.

    This waiver applies only to devices whose transmissions do not
    exceed 280 milliseconds ten times per day, with a maximum output
    power of 100 nanowatts, transmitting at 403.65 MHz +/- 75 kHz.

    This waiver applies only to devices that are typically programmed to
    operate during the late night or early morning hours, or at other
    times when the patient is usually in his or her home.

    Authorization of devices pursuant to this waiver may be granted only
    by the FCC laboratory.

    This waiver does not provide the subject devices with protection of
    transmissions by authorized users of the band. Biotronik shall
    advise medical professionals who implant devices pursuant to this
    waiver of the potential for interference from radiosondes, and shall
    advise those medical professionals in geographic areas where
    radiosondes are regularly launched of the existence of and schedules
    of such radiosonde launches.

    This waiver expires three years from the release date of this Order.
    After that time, devices implanted pursuant to this waiver may
    continue to operate, but no additional devices can be implanted in
    patients pursuant to this waiver.

    FEDERAL COMMUNICATIONS COMMISSION

    Marlene H. Dortch Secretary

[^1]: FCC ID PG6BA0T.

[^2]: Belos DR-T (dual chamber) and Belos VR-T (single chamber): FCC ID
    PG6BELOS-T.

[^3]: Lexos DR-T and Lexos VR-T: FCC ID PG6LEXOS-T.

[^4]: *Report and Order* in WT Docket No. 99-66 (Amendment of Parts 2
    and 95 of the Commission's Rules to Establish a Medical Implant
    Communications Service in the 402-405 MHz Band) ("*MICS Order*"), 14
    FCC Rcd, 21040 (1999).

[^5]: *Id.* at 21042-43.

[^6]: In this band, Metaids currently operates radiosondes, which are
    automatic transmitters, usually carried on an aircraft, free
    balloon, kite, or parachute, which transmit meteorological data
    during their journey through the atmosphere. (See 47 C.F.R. § 2.1.)

[^7]: *Id.* at 21046.

[^8]: We also provided that a MICS device could transmit without prior
    frequency monitoring, pursuant to a non-radio frequency actuation
    signal generated by a device external to the body (manual
    activation) (47 C.F.R. § 95.1209(b)), or in response to a medical
    implant event (47 C.F.R. §§ 95.628(b), 95.1209(b)). These functions
    are not the subject of the instant waiver request.

[^9]: NTIA is responsible for managing the Government portion of the
    Table of Frequency Allocations. In bands shared between Federal and
    non-Federal Government services, the Commission and NTIA operate
    under a long-standing coordination agreement. *See NTIA Manual,
    Basic Coordination Arrangement Between IRAC and the FCC*, at p.
    8-39.

[^10]: *In re Biotronik, Inc.* (*Philos MO&O*), 18 FCC Rcd. 3027 (2003).
    This decision affirmed on review the earlier action of the Office of
    Engineering and Technology (OET).

[^11]: *Id.* at 3032, 33.

[^12]: *Id.* at 3030, 32.

[^13]: *Id.* at 3032.

[^14]: *Id.*

[^15]: Request at 1. Since our decision in *Philos MO&O*, *supra*, the
    staff has certified the Biotronik Belos DR-T, a cardiac
    defibrillator with a similar monitoring and transmitting function,
    with the condition that the device not operate in a pre-programmed
    transmission mode.

[^16]: Letter from Henry Goldberg to Ms. Marlene Dortch, September 24,
    2003 ("Supplemental Letter").

[^17]: *See* *WAIT Radio v. FCC*, 459 F.2d 1203, 1207 (D.C. Cir. 1972).

[^18]: *See* 47 C.F.R. § 1.925.

[^19]: The life-saving value of this device is attested by several
    doctors and medical institutions whose letters are in the record in
    this case.

[^20]: *MICS Order*, *supra* at 21040.

[^21]: Request at 10.

[^22]: While Medtronic argues that Biotronik cannot claim that its
    device is "life critical" at the same time that it assuages NTIA's
    possible interference concerns (see below) by insisting that the
    loss of any single transmission is not life threatening (Medtronic
    Reply at 8-11), we find no such conflict in understanding that
    diagnostic cardiac data can be life-critical in aggregate, even in
    the highly unlikely event that an individual data point might be
    missing.

[^23]: Medtronic Opposition at 32, citing *Northeast Cellular Telephone
    v. FCC*, 897 F.2d 1164, 1166 (D.C. Cir., 1989).

[^24]: Request at 9, 10.

[^25]: *Philos MO&O*, *supra* 3030.

[^26]: Medtronic Opposition at 3.

[^27]: Medtronic *ex parte* filing September 26, 2003.

[^28]: *MICS Order*, *supra* at 21042-44.

[^29]: Medtronic cites devices that operate at 128 kHz and 433 MHz.

[^30]: Letter from Frederick R. Wentland to Edmond J. Thomas, May 22,
    2003.

[^31]: In addition to its certification for the Belos devices, which
    restricts their use to nonpre-programmed transmissions, Biotronik
    holds an experimental license for these devices to operate with a
    pre-programmed function pursuant to the Commission's experimental
    rules. License nos. WC2XWI, WD2XAA.

[^32]: 47 C.F.R. § 5.93.

[^33]: See File No. 0223-EX-PL-2002, Response to Medtronic Opposition;
    letter from Henry Goldberg, counsel for Biotronik to James Burtle,
    Chief, Experimental Licensing Branch, February 11, 2003.

[^34]: Medtronic Opposition at 9; Medtronic Reply at 7.

[^35]: We will not, of course, require the removal of devices
    appropriately implanted pursuant to this waiver.