[Federal Register: March 10, 2005 (Volume 70, Number 46)]
[Page 11986-11987]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2004M-0538, 2004M-0495, 2004M-0450, 2004M-0467, 2004M-
0471, 2004M-0533, 2004M-0496, 2004M-0497]

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

[[Page 11987]]

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 October 1, 2004, through December 31, 
2004. 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, 2004, through December 31, 2004
  PMA No./Docket
       No.           Applicant     Trade Name         Approval Date
P020022/2004M-     Bayer         BAYER VERSANT            March 28, 2003
 0538               Healthcare,   HCV RNA 3.0
                    LLC           ASSAY (bDNA)
P020021/2004M-     Wilson-Cook   WIZARD X-CELL            August 1, 2003
 0495               Medical,      PHOTODYNAMIC
                    Inc./         THERAPY
                    applicant     BALLOON WITH
                    at approval   FIBER OPTIC
                    was Axcan     DIFFUSER
                    , Inc.
P040029/2004M-     Szabocsik &   JSZ                  September 29, 2004
 0450               Associates    ORTHOKERATOLO
                                  GY (OPRIFOCON
                                  A) CONTACT
                                  LENSES FOR
P030032(S1)/2004M- Genzyme       HYLAFORM PLUS          October 13, 2004
 0467               Biosurgery    (HYLAN B GEL)
P030011/2004M-     Syncardia     SYNCARDIA              October 15, 2004
 0471               Systems,      TEMPORARY
                    Inc.          CARDO WEST
                                  HEART (TAH-t)
P040002/2004M-     Endologix,    ENDOLOGIX              October 29, 2004
 0533               Inc.          POWERLINK
P040022/2004M-     Medtronic,    EVS VASCULAR           November 3, 2004
 0496               Inc./         CLOSURE
                    applicant     SYSTEM
                    at approval
P030031/2004M-     Biosense      BIOSENSE               November 5, 2004
 0497               Webster,      WEBSTER
                    Inc.          NAVISTAR/
                                  TIP CATHETERS

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4763 Filed 3-9-05; 8:45 am]