[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Page 61447-61448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 61447]]



Food and Drug Administration

[Docket Nos. 2003M-0045, 2003M-0122, 2003M-0010, 2003M-0040, 2003M-
0086, 2003M-0116, 2003M-0049, 2003M-0070, 2003M-0011, 2003M-0046, 
2003M-0114, 2003M-0115]

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 
revised 21 CFR 814.44(d) and 814.45(d) (63 FR 4571) to discontinue 
individual publication of PMA approvals and denials in the Federal 
Register. Instead, the agency now posts this information to FDA's home 
page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov on the Internet. 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 January 1, 2003, through March 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 January 1, 2003, through March 31, 2003
 PMA No./
Docket No.    Applicant          Trade Name             Approval Date
P990071/    Biosense      STOCKERT 70 RF GENERATOR         May 31, 2000
 03M-0045    Webster,      FOR CARDIAC ABLATION
P980048/    Sulzer Spine- BAK/CERVICAL (BAK/C)           April 20, 2001
 03M-0122    Tech          INTERBODY FUSION SYSTEM
P990065/    Sirtex        SIR-SPHERES                     March 5, 2002
 03M-0010    Medical,
P010002/    United        INDERMIL TISSUE ADHESIVE         May 22, 2002
 03M-0040    States
P010041/    Edwards       CARPENTIER-EDWARDS              June 24, 2002
 03M-0086    Lifescience   S.A.V. BIOPROSTHESIS,
             s, LLC        MODEL 2650 (AORTIC)
P020009/    Boston        EXPRESS/EXPRESS 2          September 11, 2002
 03M-0116    Scientific,   MONOTRAIL AND OVER THE
             Scimed,       WIRE CORONARY STENT
             Inc.          SYSTEMS
P010068/    Biosense      NAVISTAR DS/CELSIUS DS     September 27, 2002
 03M-0049    Webster,      DIAGNOSTIC ABLATION
             Inc.          CATHETERS, STOCKERT 70
                           GENERATOR, AND CATHETER
                           INTERFACE CABLES
P020011/    Gen-Probe,    VERSANT HCV RNA              November 7, 2002
 03M-0070    Inc.          QUALITATIVE ASSAY
P020008/    Karl Storz    KARL STORZ                  December 12, 2002
 03M-0011    Endoscopy-    AUTOFLUORESCENCE SYSTEM
P020027/    Dade          DIMENSION FPSA FLEX          January 24, 2003
 03M-0046    Behring,      REAGENT CARTRIDGE AND
             Inc.          DIMENSION T/F PSA
                           CALIBRATOR FOR
                           DIMENSION RXL AND XPAND
P800022(S5  Inamed Corp.  COSMODERM 1 & COSMOPLAST       March 11, 2003
 0)/03M-                   HUMAN-BASED COLLAGEN
P010065/    E Med Future  NEEDLE ZAP                     March 14, 2003

[[Page 61448]]

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: October 6, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27119 Filed 10-27-03; 8:45 am]