[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Pages 6642-6643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2685]



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.


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.


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 
    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
P060027        ELA Medical, Inc.  OVATIO CRT-D SYSTEM         May 15,
FDA-2008-M-04                                                  2008
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
P050040        Invitrogen         SPOT-LIGHT HER2 CISH KIT    July 1,
FDA-2008-M-04   Corporation                                    2008
P070006        Oxford Immunotec,  T SPOT-TB TEST              July 30,
FDA-2008-M-04   Ltd.                                           2008
P040037        W.L. Gore &        VIABAHN ENDOPROSTHESIS      August 14,
 (S007)         Associates, Inc.                               2008
P050028        Roche Molecular    COBAS TAQMAN HBV TEST       September
FDA-2008-M-05   Systems, Inc.                                  4, 2008
P060022        Bausch & Lomb,     AKREOS POSTERIOR CHAMBER    September
FDA-2008-M-05   Inc.               INTRAOCULAR LENS            5, 2008

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    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]