Document ID: FDA-2010-M-0068-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2010-07-02T04:00Z

[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Notices]
[Pages 38532-38533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-M-0068, FDA-2010-M-0078, FDA-2010-M-0063, FDA-
2010-M-0135, FDA-2010-M-0158]

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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

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, 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

[[Page 38533]]

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 January 1, 2010, through March 31, 
2010. 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 January 1, 2010, through March 31, 2010
------------------------------------------------------------------------
 PMA No.  Docket                                               Approval
       No.            Applicant            Trade Name            Date
------------------------------------------------------------------------
P010047            Neomend, Inc.   PROGEL PLEURAL AIR LEAK    January
FDA-2010-M-0068                     SEALANT                    14, 2010
------------------------------------------------------------------------
P060040/S005       Thoratec Corp.  THORATEC HEARTMATE II      January
FDA-2010-M-0078                     LEFT VENTRICULAR ASSIST    20, 2010
                                    SYSTEM (LVAS)
------------------------------------------------------------------------
H080002            Medtronic,      MEDTRONIC MELODY           January
FDA-2010-M-0063     Inc.            TRANSCATHETER PULMONARY    25, 2010
                                    VALVE (MODEL PB10) AND
                                    MEDTRONIC ENSEMBLE
                                    TRANSCATHETER VALVE
                                    DELIVERY SYSTEM (NU10)
------------------------------------------------------------------------
P090003            Boston          EXPRESS LD LLIAC           March 5,
FDA-2010-M-0135     Scientific      PREMOUNTED STENT SYSTEM    2010
                    Corp.
------------------------------------------------------------------------
P090006            Medtronic       COMPLETE SE VASCULAR       March 17,
FDA-2010-M-0158     Vascular        STENT SYSTEM               2010
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: June 28, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for 
Devices and Radiological Health.
[FR Doc. 2010-16139 Filed 7-1-10; 8:45 am]
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