[Federal Register: July 15, 2005 (Volume 70, Number 135)]
[Page 41041-41043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2005M-0024, 2005M-0025, 2005M-0026, 2005M-0092, 2005M-
0087, 2005M-0055, 2005M-0089, 2005M-0027, 2005M-0109, 2005M-0028, 
2005M-0088, 2005M-0110, 2005M-0132]

Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


[[Page 41042]]

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, 2005, through March 31, 
2005. 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 January 1, 2005, through March 31, 2005
PMA No./Docket No.     Applicant          TRADE NAME       Approval Date
P010058/2005M-0024  Medilink         OSTEOSPACE            March 15,
P030029/2005M-0025  Bayer            ADVIA CENTAUR ANTI    May 14, 2005
                     HealthCare,      HBs READYPACK
                     LLC              REAGENTS & ADVIA
                                      CENTAUR ANTI HBs
P030028/2005M-0026  Ophtec USA,      ARTISAN (MODEL 206 &  September 10,
                     Inc.; Ophtec     204) PHAKIC           2004
                     BV               INTRAOCULAR LENS
                                      (PIOL) VERISYSE
                                      (VRSM5US & VRMA6US)
                                      PHAKIC INTRAOCULAR
P040006/2005M-0092  DePuy Spine,     CHARITE ARTIFICIAL    October 26,
                     Inc.             DISC                  2004
P030007/2005M-0087  Eastman Kodak    KODAK MAMMAGRAPHY     November 23,
                     Co.              CAD ENGINE            2004
P930016 (S17)/      VISX, Inc.       STAR S4 EXCIMER       December 14,
 2005M-0055                           LASER SYSTEM WITH     2004
                                      VARIABLE SPOT
                                      SCANNING (VSS) &
                                      WAVESCAN WAVEFRONT
P030030/2005M-0089  Genyx Medical    URYX URETHRAL         December 16,
                                      BULKING AGENT         2004
P030022/2005M-0027  Smith & Nephew,  REFLECTION CERAMIC    December 17,
                     Inc.             ACETABULAR SYSTEM     2004
P040004/2005M-0109  Bayer            ADVIA CENTAUR HBC     December 22,
                     Healthcare LLC   TOTAL READY PAK       2004
                                      REAGENTS & ADVIA
                                      CENTAUR HBC TOTAL
                                      QUALITY CONTROL
P030034/2005M-0028  Orthofix, Inc.   CERVICAL-STIM MODEL   December 23,
                                      505L CERVICAL         2004
                                      FUSION SYSTEM
P040014/2005M-0088  Irvine           IBI THERAPY CARDIAC   January 14,
                     Biomedical,      ABLATION SYSTEM       2005

[[Page 41043]]

P040017/2005M-0110  Bayer            ADVIA CENTAUR ANTI-   March 7, 2005
                     Healthcare,      HAV TOTAL ASSAY &
                     LLC              ADVIA CENTAUR TOTAL
                                      QUALITY CONTROL
H030005/2005M-0132  CoAxia, Inc.     COAXIA NEUROFLO       March 30,
                                      CATHETER              2005

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: July 6, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-13901 Filed 7-14-05; 8:45 am]