[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Notices]
[Pages 67629-67631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28155]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 02M-0250, 02M-0203, 02M-0180, 02M-0218, 02M-0272, 02M-
0271, 02M-0145, 02M-0311, 02M-0172, 02M-0217, 02M-0179, 02M-0255, 02M-
0173, 02M-0235, 02M-0167, 02M-0174, 02M-0216, and 02M-0236]


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 Dockets Management Branch.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness to the Dockets Management Branch (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: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION:

I. Background

    In January 1998, FDA revised 21 CFR 814.44(d) and 814.45(d) (63 FR 
4571, January 30, 1998) to discontinue individual publication of PMA 
approvals and denials in the Federal Register, providing instead to 
post this information to FDA's home page at

[[Page 67630]]

http://www.fda.gov on the Internet. In addition, 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. 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 following is a list of approved PMAs for which summaries of 
safety and effectiveness were placed on the Internet in accordance with 
the procedure described above from April 1, 2002, through June 30, 
2002. 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 April 1, 2002, Through June 30, 2002
------------------------------------------------------------------------
PMA Number/Docket
       No.             Applicant         Trade Name       Approval Date
------------------------------------------------------------------------
P000008/02M-0250   BioEntrics Corp.   LAP-BAND          June 5, 2001.
                                       Adjustable
                                       Gastric Banding
                                       System
P980033/02M-0203   Boston Scientific  WALLSTENT         November 16,
                    Scimed, Inc.       Endoprosthesis    2001.
P010027/02M-0180   Ophthalmic         ALLERGAN, INC.    November 21,
                    Innovations        Model AC 21B      2001.
                    International,     Anterior
                    Inc.               Chamber
                                       Intraocular
                                       Lens (Cataract)
P010033/02M-0218   Cellestis Ltd.     QUANTIFERON-TB    November 28,
                                                         2001.
P000049/02M-0272   Nitinol Medical    CARDIOSEAL        December 5,
                    Technologies,      Septal            2001.
                    Inc.               Occlusion
                                       System With
                                       QWIKLOAD
P000039/02M-0271   AGA Medical Corp.  THE AMPLATZER     December 5,
                                       Septal Occluder   2001.
                                       (ASO) And
                                       AMPLATZER
                                       Exchange System
P010030/02M-0145   Lifecor, Inc.      Wearable          December 18,
                                       Cardioverter      2001.
                                       Defibrillator
                                       (WCD) 2000
                                       ``Lifevest''
                                       System
H000002/02M-0311   VISX, Inc.         VISX EXCIMER      December 19,
                                       LASER SYSTEM      2001.
                                       AND CUSTOM
                                       CONTOURED
                                       ABLATION
                                       PATTERN (C0-
                                       CAP) METHOD
P980024(S1)/02M-   Vysis              PATHVYSION HER-2  December 31,
 0172                                  DNA Probe Kit     2001.
P9600009(S7)/02M-  Medtronic, Inc.    MEDTRONIC ACTIVA  January 14,
 0217                                  Parkinson's       2002.
                                       Control System
P010054/02M-0179   Roche Diagnostics  ELECSYS ANTI-HBS  February 28,
                    Co.                Immunoassay       2002.
                                       PRECICONTROL
                                       ANTI02M-HBS
P000037(S1)/02M-   Medical Carbon     ON-X Prosthetic   March 6, 2002.
 0255               Research           Heart Valve,
                    Institute, LLC     Models ONXM and
                                       ONXMC
P010025/02M-0173   Hologic, Inc.      LORAD Digital     March 15, 2002.
                                       Breast Imager
P000033/02M-0235   SulzerIntra        INTRACOIL Self-   April 3, 2002.
                    Therapeutics,      Expanding
                    Inc.               Peripheral
                                       Stent
H000007/02M-0167   AGA Medical Corp.  AMPLATZER PFO     April 5, 2002.
                                       Occluder
P010018/02M-0174   Refractec, Inc.    VIEWPOINT CK      April 11, 2002.
                                       SYSTEM
P900033(S8)/02M-   Integra            INTEGRA Dermal    April 19, 2002.
 0216               Lifesciences,      Regeneration
                    Corp.              Template
P010012/02M-0236   Guidant Corp.      CONTAK CD/        May 2, 2002.
                                       EASYTRAK Lead
                                       System, Models
                                       4510, 4511,
                                       4512, And 4513
------------------------------------------------------------------------


[[Page 67631]]

II. Electronic Access

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

    Dated: October 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28155 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S