[Federal Register: May 7, 2004 (Volume 69, Number 89)]
[Page 25593-25594]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2003M-0337, 2003M-0332, 2003M-0343, 2003M-0242, 2003M-
0333, 2003M-0339, 2003M-0320, 2003M-0356, 2003M-0305, 2003M-0352, 
2003M-0381, 2003M-0375, 2003M-0427]

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 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, 2003, through September 30, 
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 July 1, 2003, Through September 30, 2003
  PMA No./Docket
       No.             Applicant         Trade Name       Approval Date
P000013/2003M-     Howmedica          OSTEONICS ABC     February 3, 2003
 0337               Ostenonics Corp.   SYSTEM &
                                       TRIDENT SYSTEM
                                       HIP PROSTHESIS
P010001/2003M-     Ceramtec AgWright  CERAMIC           February 3, 2003
 0332               Medical            TRANSCEND HIP
                    Technology         ARTICULATION
P020052/2003M-     St. Jude Medical,  RESPONSE CV       May 7, 2003
 0343               Daig Division,     CATHETER SYSTEM

[[Page 25594]]

P020018/2003M-     Cook, Inc.         ZENITH AAA        May 23, 2003
 0242                                  ENDOVASCULAR
                                       GRAFT AND H&L-B
P930016(S16)/      Visx, Inc.         STAR S4 ACTIVE    May 23, 2003
 2003M-0333                            TRAK EXCIMER
                                       LASER SYSTEM
                                       AND WAVE SCAN
                                       WAVE FRONT
P020002/2003M-     Cytyc Corp.        THINPREP IMAGING  June 6, 2003
 0339                                  SYSTEM
P020037/2003M-     X Technologies     FX MINIRAIL RX    June 11, 2003
 0320                                  PTCA CATHETER
P030027/2003M-     Wright Cremascoli  CERAMIC           July 7, 2003
 0356               Ortho, SA          TRANSCEND HIP
H020004/2003M-     Smith & Nephew     DERMAGRAFT        July 7, 2003
 0305               Wound Management
P020049/2003M-     Hancock/Jaffe      PROCOL VASCULAR   July 29, 2003
 0352               Laboratories       BIOPROSTHESIS
P020036/2003M-     Cordis Corp.       SMART AND SMART   August 12, 2003
 0381                                  CONTROL NITINOL
                                       STENT SYSTEM
P020033/2003M-     Independence       INDEPENDENCE      August 13, 2003
 0375               Technology, LLC    IBOT 3000
                                       MOBILITY SYSTEM
P020025/2003M-     Boston Scientific  EP TECHNOLOGIES   August 25, 2003
 0427                                  EPT 1000 XP RF
                                       ABLATION SYSTEM

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. 04-10450 Filed 5-6-04; 8:45 am]