Document ID: FDA-2009-M-0016-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2009-10-06T04:00Z

[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]               
[Page 51288-51289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-M-0033, FDA-2009-M-0016, FDA-2009-M-0034, FDA-
2009-M-0049, FDA-2009-M-0071, FDA-2009-M-0127, FDA-2009-M-0128, FDA-
2009-M-0135, FDA-2009-M-0159]

 
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, 10903 
New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 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

[[Page 51289]]

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 January 1, 2009, through March 31, 
2009. 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, 2009, through March 31, 2009
------------------------------------------------------------------------
                                                              Approval
PMA No.  Docket No.      Applicant          Trade Name          Date
------------------------------------------------------------------------
P060030              Roche Molecular   Cobas ampliprep/     October 30,
FDA-2009-M-0033       Systems, Inc.     cobas taqman HFC     2008
                                        test
------------------------------------------------------------------------
P950009 (S8)         BD Diagnostics    BD focal point gs    December 3,
FDA-2009-M-0016                         imaging system       2008
------------------------------------------------------------------------
P080010              Advanced Medical  Tecnis multifocal    January 16,
FDA-2009-M-0034       Optics, Inc.      foldable posterior   2009
                                        chamber
                                        intraocular lens
------------------------------------------------------------------------
P080021              Advanced Vision   xact foldable        February 2,
FDA-2009-M-0049       Science, Inc.     hydrophobic          2009
                                        acrylic UV light
                                        absorbing
                                        posterior chamber
                                        IOL
------------------------------------------------------------------------
P030031 (S11)        Biosense          Navistar & Celsius   February 6,
FDA-2009-M-0071       Webster, Inc.     thermo cool          2009
                                        catheters
------------------------------------------------------------------------
P070014              Bard Peripheral   lifestent flexstar   February 13,
FDA-2009-M-0127       Vascular, Inc.    & flexstar XL        2009
                                        vascular stent
                                        system
------------------------------------------------------------------------
P940015 (S12)        Genzyme Corp.     Synvisc-One          February 26,
FDA-2009-M-0128                                              2009
------------------------------------------------------------------------
P070005              Synthemed Corp.   Repel-cv             March 6,
FDA-2009-M-0135                         bioresorbable        2009
                                        adhesion barrier
------------------------------------------------------------------------
P080002              The Female        FC2 female condom    March 10,
FDA-2009-M-0159       Health Co.                             2009
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: September 24, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-23962 Filed 10-5-09; 8:45 am]

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