Document ID: FDA-2008-M-0402-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2009-02-10T05:00Z

[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6642-6643]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe09-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2008-M-0522, FDA-2008-M-0425, FDA-2008-M-0426, FDA-
2008-M-0478, FDA-2008-M-0402, FDA-2008-M-0437, FDA-2008-M-0477, FDA-
2008-M-0467, FDA-2008-M-0501, FDA-2008-M-0515]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in Table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4010.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead,

[[Page 6643]]

the agency now posts this information on the Internet on FDA's home
page at http://www.fda.gov. FDA believes that this procedure expedites
public notification of these actions because announcements can be
placed on the Internet more quickly than they can be published in the
Federal Register, and FDA believes that the Internet is accessible to
more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from July 1, 2008, through September 30,
2008. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

  Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
      Made Available From July 1, 2008, through September 30, 2008.
------------------------------------------------------------------------
   PMA No.                                                     Approval
  Docket No.       Applicant              TRADE NAME             Date
------------------------------------------------------------------------
P060037        Zimmer, Inc.       NEXGEN LPS-FLEX MOBILE &    December
FDA-2008-M-05                      LPS MOBILE BEARING KNEE     10, 2007
 22                                SYSTEM
------------------------------------------------------------------------
P850048        Beckman Coulter,   ACCESS HYBRITECH PSA        May 9,
 (S021)         Inc.               REAGENTS                    2008
FDA-2008-M-04
 25
------------------------------------------------------------------------
P060027        ELA Medical, Inc.  OVATIO CRT-D SYSTEM         May 15,
FDA-2008-M-04                                                  2008
 26
------------------------------------------------------------------------
P060039        Medtronic Cardiac  ATTAIN STARFIX MODEL 4195   June 13,
FDA-2008-M-04   Rhythm Disease     LEAD                        2008
 78             Management
------------------------------------------------------------------------
P070013        Colbar             EVOLENCE COLLAGEN FILLER    June 27,
FDA-2008-M-04   Lifescience Ltd.                               2008
 02
------------------------------------------------------------------------
P050040        Invitrogen         SPOT-LIGHT HER2 CISH KIT    July 1,
FDA-2008-M-04   Corporation                                    2008
 37
------------------------------------------------------------------------
P070006        Oxford Immunotec,  T SPOT-TB TEST              July 30,
FDA-2008-M-04   Ltd.                                           2008
 77
------------------------------------------------------------------------
P040037        W.L. Gore &        VIABAHN ENDOPROSTHESIS      August 14,
 (S007)         Associates, Inc.                               2008
FDA-2008-M-04
 67
------------------------------------------------------------------------
P050028        Roche Molecular    COBAS TAQMAN HBV TEST       September
FDA-2008-M-05   Systems, Inc.                                  4, 2008
 01
------------------------------------------------------------------------
P060022        Bausch & Lomb,     AKREOS POSTERIOR CHAMBER    September
FDA-2008-M-05   Inc.               INTRAOCULAR LENS            5, 2008
 15
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.

    Dated: January 15, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-2685 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S