[Federal Register: June 25, 2004 (Volume 69, Number 122)]
[Page 35654-35655]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2004M-0024, 2004M-0147, 2004M-0145, 2004M-0031, 2004M-
0022, 2004M-0012, 2004M-0064, 2004M-0116, 2004M-0084, 2004M-0090, 

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 January 1, 2004, through March 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.

[[Page 35655]]

 Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
       Made Available From January 1, 2004, through March 31, 2004
  PMA No./Docket
       No.             Applicant         Trade Name       Approval Date
P970020(S40)/      Guidant Corp.      ACS MULTI-LINK    August 6, 2002
 2004M-0024                            RX/OTW DUET
                                       CORONARY STENT
P890064(S9)/2004M- Digene Corp.       DIGENE HYBRID     March 31, 2003
 0147                                  CAPTURE 2 (HC2)
                                       HIGH-RISK HPV
                                       DNA TEST
P020006/2004M-     Enteric Medical    ENTERYX           April 22, 2003
 0145               Technologies,      PROCEDURE KIT
P020031/2004M-     Microsulis Corp.   MICROSULIS        September 23,
 0031                                  MICROWAVE         2003
P010059/2004M-     Morcher GMBH       MORCHER CAPSULAR  October 23, 2003
 0022                                  TENSION RING,
                                       TYPES 14, 14A,
                                       and 14C
P030002/2004M-     Eyeonics, Inc.     CRYSTALENS MODEL  November 14,
 0012                                  AT-45             2003
P030005/2004M-     Guidant Corp.       CONTAK RENEWAL   January 26, 2004
 0064                                  MODELS H125 and
                                       H120 WITH MODEL
                                       2865 VERSION
                                       1.8 APPLICATION
P030006/2004M-     Celsion Corp.       PROLIEVE          February 19,
 0116                                  THERMODILATION    2004
H030004/2004M-     Menssana           HEARTSBREATH      February 24,
 0084               Research, Inc.                       2004
H030003/2004M-     MicroMed            DEBAKEY VAD       February 25,
 0090               Technology, Inc.   CHILD LEFT        2004
                                       ASSIST SYSTEM
P010018(S5)/2004M- Refractec, Inc.    VIEWPOINT CK       March 16, 2004
 0134                                  SYSTEM

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: June 7, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-14439 Filed 6-24-04; 8:45 am]