[Federal Register Volume 67, Number 9 (Monday, January 14, 2002)]
[Notices]
[Pages 1773-1774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-853]



[[Page 1773]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 01M-0309, 01M-0342, 01M-0329, 01M-0381, 01M-0371, 01M-
0412, 01M-0305, 01M-0337, 01M-0296, 01M-0310, 01M-0306, 01M-0307, 01M-
0360, 01M-0380, 01M-0373, 01M-0392, 01M-0413, 01M-0414, 01M-0439]


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 Dockets Management Branch.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness to the Dockets Management Branch (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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule to revise Secs.  814.44(d) and 814.45(d) (21 CFR 
814.44(d) and 814.45(d)) to discontinue publication of individual PMA 
approvals and denials in the Federal Register. Instead, revised Secs.  
814.44(d) and 814.45(d) state that FDA will notify the public of PMA 
approvals and denials by posting them on the Internet at http://www.fda.gov; by placing the summaries of safety and effectiveness on 
the Internet and in FDA's Dockets Management Branch; and by publishing 
in the Federal Register after each quarter a list of available safety 
and effectiveness summaries of approved PMAs and denials announced in 
that quarter.
    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 
decision.
    The following is a list of approved PMAs for which summaries of 
safety and effectiveness were placed on the Internet from July 1, 2001, 
through September 30, 2001, in accordance with the procedure explained 
previously. 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 July 1, 2001, through
                                               September 30, 2001
----------------------------------------------------------------------------------------------------------------
  PMA No./Docket No.             Applicant                        Trade Name                   Approval Date
----------------------------------------------------------------------------------------------------------------
P970056/01M-0309       Bausch & Lomb Surgical        KERACOR 116 Ophthalmic Excimer Laser  September 28, 1999
                                                      System
P980044/01M-0342       Quintiles, Inc.               SUPARTZ Dispo                         January 24, 2001
P000016/01M-0329       GE Medical Systems            Corometrics Model 120 F-Series        February 9, 2001
                        Information Technologies      Maternal/Fetal Monitor with
                                                      Integrated Fetal Oxygen Saturation
                                                      Monitoring, Corometrics Fetal
                                                      Patient Module, and the Nellcor
                                                      OXIFIRST FS14 Sensor
P000007/01M-0381       Edwards Lifesciences, LLC     EDWARDS PRIMA Plus Bioprosthesis      February 27, 2001
                                                      Model 2500P
P990026/01M-0371       Cygnus, Inc.                  GLUCOWATCH Automatic Glucose          March 22, 2001
                                                      Biographer
P000032/01M-0412       CryoGen, Inc.                 HEROPTION UTERINE CRYOBLATION         April 20, 2001
                                                      THERAPY System
P930016(S12)/01M-0305  VISX, Inc.                    STAR Excimer Laser System Models S2   April 27, 2001
                                                      and S3
P000005/01M-0337       MediTeam AB                   CARISOLV Non-Invasive Dental Caries   June 27, 2001
                                                      Removal System
P000043/01M-0296       TherMatrx, Inc.               TMx2000 BPH Thermotherapy System      June 29, 2001
P000021/01M-0310       Dade Behring, Inc.            DIMENSION RxL PSA Reagent Cartridge   July 5, 2001
P000041/01M-0306       Deus Technologies, LLC        RAPIDSCREEN RS-2000                   July 12, 2001
P000026/01M-0307       STAAR Surgical Co.            AQUAFLOW Collegen Glaucoma Drainage   July 12, 2001
                                                      Device, Model CGDD-20
P000055/01M-0360       Diagnostic Medical Systems    UBIS 5000                             July 17, 2001
P830039(S7)/01M-0380   Medical CV, Inc.              OMNICARBON Cardiac Valve Prosthesis   July 26, 2001
P010015/01M-0373       Medtronic, Inc.               INSYNC Biventricular Pacing System    August 28, 2001
                                                      including INSYNC Model 8040 Pulse
                                                      Generator, ATTAIN LV Model 2187 and
                                                      ATTAIN CS Model 2188 Leads
H010001/01M-0392       Avanta Orthopaedics, Inc.     Avanta Metacarpophalangeal (MCP)      August 28, 2001
                                                      Joint Implant Finger Prosthesis
P010016/01M-0413       Ortec International, Inc.     ORCEL (Bilayered Cellular Matrix)     August 31, 2001

[[Page 1774]]

 
P010023/01M-0414       SOUNDTEC, Inc.                SOUNDTEC Direct System                September 7, 2001
P000029/01M-0439       Q-Med AB                      DEFLUX Injectable Gel                 September 24, 2001
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: December 31, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-853 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-01-S