[Federal Register: May 7, 2004 (Volume 69, Number 89)]
[Page 25594-25595]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2003M-0532, 2003M-0487, 2003M-0488, 2003M-0499, 2003M-
0490, 2003M-0491, 2003M-0492, 2003M-0533, 2003M-0524, 2003M-0536, 
2003M-0569, 2003M-0560]

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 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: Thinh Nguyen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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

[[Page 25595]]

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 October 1, 2003, through December 31, 
2003. 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 October 1, 2003, through December 31, 2003
  PMA No./Docket
       No.             Applicant         Trade Name       Approval Date
P000028/2003M-     Medtronic, Inc.    AFFINITY CAGE     June 13, 2002
 0532               (Sofamor Danek)    SYSTEM
P020007/2003M-     Medtronic AVE,     MEDTRONIC AVE     December 18,
 0487               Inc.               BRIDGE EXTRA      2002
                                       SUPPORT OVER-
                                       THE-WIRE RENAL
                                       STENT SYSTEM
P020041/2003M-     Femcap, Inc.       FEMCAP BARRIER    March 28, 2003
 0488                                  CONTRACEPTIVE
P020047/2003M-     Guidant Corp.      MULTI-LINK RX/    July 16, 2003
 0499                                  OTW VISION
                                       CORONARY STENT
P030009/2003M-     Medtronic          DRIVER OVER-THE-  October 1, 2003
 0490               Vascular           WIRE, RAPID
                                       EXCHANGE, AND
                                       CORONARY STENT
P020050/2003M-     Wavelight Laser    WAVELIGHT         October 7, 2003
 0491               Technologies       ALLEGRETTO WAVE
                    (SurgiVision       EXCIMER LASER
                    Refractive         SYSTEM
P030008/2003M-     Wavelight Laser    WAVELIGHT         October 10, 2003
 0492               Technologies       ALLEGRETTO WAVE
                    (SurgiVision       EXCIMER LASER
                    Refractive         SYSTEM
P9900027(S6)/      Bausch & Lomb      BAUSCH & LOMB     October 10, 2003
 2003M-0533         Surgical, Inc.     TECHNOLAS 217Z
                                       ZYOPTIX SYSTEM
P020040/2003M-     Medinol Ltd.       NIRFLEX PRE-      October 24, 2003
 0524                                  MOUNTED
                                       CORONARY STENT
H020003/2003M-     Medtronic, Inc.    CONTEGRA          November 21,
 0536                                  PULMONARY         2003
                                       VALVED CONDUIT
D980003/2003M-     Encore Medical,    KERAMOS CERAMIC/  November 26,
 0569               LP                 CERAMIC TOTAL     2003
                                       HIP SYSTEM
P030039/2003M-     Baxter Bio         COSEAL SURGICAL   December 12,
 0560               Science (Baxter    SEALANT           2003

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: April 26, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-10459 Filed 5-6-04; 8:45 am]