[Federal Register: November 6, 2003 (Volume 68, Number 215)]
[Page 62812-62813]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2003M-0287, 2003M-0271, 2003M-0272, 2003M-0262, 2003M-
0175, 2003M-0240, 2003M-0189, 2003M-0241, 2003M-0332, 2003M-0337, 
2003M-0174, 2003M-0173, 2003M-0190, 2003M-0343, 2003M-0242, 2003M-0333, 
2003M-0339, 2003M-0320, 2003M-0352, 2003M-0157]

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 January 30, 1998 (63 FR 4571), FDA 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 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 April 1, 2003, through June 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 April 1, 2003, through June 30, 2003
 PMA No./Docket                                               Approval
      No.            Applicant            Trade Name            Date
P010052/2003M-   Diagnostic         Immulite/Immulite 2000  July 22,
 0287             Products Corp.     Anti-HBS                2002
P010051/2003M-   Diagnostic         Immulite/Immulite 2000  July 24,
 0271             Products Corp.     Anti-HBC                2002
P010053/2003M-   Diagnostic         Immulite/Immulite 2000  July 26,
 0272             Products Corp.     Anti-HBC IGM            2002
P010050/2003M-   Diagnostic         Immulite/Immulite 2000  July 26,
 0262             Products Corp.     HBSAF                   2002
                                    and Immulite HBSAF
                                     Confirmatory Kit
P020014/2003M-   Conceptus, Inc.    Essure System           November 4,
 0175                                                        2002
P990069/2003M-   EpMed Systems,     Alert System (Alert     November 27,
 0240             Inc.               Catheter, Alert         2002
                                    Interface Cable, and
                                     Alert Companion With
                                     Software Version
P010055/2003M-   Prostalund         Prostalund Coretherm    December 23,
 0189             Operations AB      System Microwave        2002
                                     Thermotherapy for BPH
P020028/2003M-   Philips Medical    Series 50 XMO (Model    January 3,
 0241             System             M1350C) Fetal/          2003
                                     Maternal Monitor
                                    System With Integrated
                                     Fetal Oxygen
                                     Saturation Monitoring

[[Page 62813]]

P990027(S004)/   Bausch & Lomb      Technolas 217A Excimer  February 25,
 2003M-0174       Surgical, Inc.     Laser System            2003
P990086(S003)/   Health Tronics     Healthtronics Ossatron  March 14,
 2003M-0173       Surgical                                   2003
                  Services, Inc.
P980035(S013)/   Medtronic, Inc.    Medtronic AT500 DDDRP   March 27,
 2003M-0190                          Pacing System           2003
                                    (Model A1501) and
                                     Model 9968 Software
H020007/2003M-   Medtronic          Medtronic Activa        April 15,
 0157             Neurological       Dystonia Therapy        2003

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: October 20, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27882 Filed 11-5-03; 8:45 am]