[Federal Register Volume 68, Number 8 (Monday, January 13, 2003)]
[Notices]
[Pages 1620-1621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 02M-0298, 02M-0299, 02M-0295, 02M-0381, 02M-0310, 02M-
0348, 02M-0335, 02M-0353, 02M-0352, 02M-0336, 02M-0322, 02M-0361, 02M-
0412, 02M-0409]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 that revised 21 CFR 814.44(d) and 814.45(d) to 
discontinue individual publication of PMA approvals and denials in the 
Federal Register, providing instead to post this information on the 
Internet on FDA's home page at http://www.fda.gov. In addition, 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. 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, 2002, 
through September 30, 2002. 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 1621]]



 Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
        Made Available July 1, 2002, through September 30, 2002.
------------------------------------------------------------------------
 PMA Number/Docket                                            Approval
        No.            Applicant          Trade Name            Date
------------------------------------------------------------------------
P990017(S30)/02M-   Guidant         ANCURE Aortoiliac       April 24,
 0298                Cardiac and     Endograft System        2002.
                     Vascular
                     Surgery
                     Group.
P990027(S2)/02M-    Bausch & Lomb   TECHNOLAS 217A Excimer  May 17,
 0299                Surgical,       Laser System            2002.
                     Inc.
P870024(S43)/02M-   Paragon Vision  PARAGON CRT             June 13,
 0295                Sciences.       (Paflufocon B),         2002.
                                     PARAGON CRT 100
                                     (Paflufocon D),
                                     PARAGON QUADRA RG
                                     (Paflufocon B), and
                                     PARAGON QUADRA RG 100
                                     (Paflufocon D).
P010031/02M-0381    Medtronic,      INSYNC ICD Model 7272   June 26,
                     Inc.            Dual Chamber            2002.
                                     Implantable
                                     Cardioverter With
                                     Resynchronization
                                     Therapy and Model
                                     9969 Application
                                     Software.
P000058/02M-0310    Medtronic       INFUSE BONE GRAFT/LT-   July 2,
                     Sofamor         CAGE Lumbar Tapered     2002.
                     Danek, Inc.     Fusion Device.
P890017(S10)/02M-   Cordis Corp.    PALMAZ Balloon-         July 10,
 0348                                Expandable Stent        2002.
                                     (Models P104R, P154R,
                                     P204R).
P990018(S2)/02M-    Menicon Co.,    MENICON Z (Tisilfocon   July 12,
 0335                Ltd.            A) Rigid Gas            2002.
                                     Permeable Contact
                                     Lens.
P960040(S26)/02M-   Guidant Corp.   VENTAK PRIZM 2 VR/DR    July 18,
 0353                                Models 1860/1861;       2002.
                                     VENTAK PRIZM VR/DR
                                     Models 1850/1851/1855/
                                     1856; VENTAK PRIZM VR/
                                     DR HE Models 1852/
                                     1853, VENTAK Mini IV
                                     Models 1790/1793/
                                     1796; and VENTAK Mini
                                     III HE Model 1789.
P910077(S37)/02M-   Guidant Corp.   VENTAK PRIZM 2 VR/DR    July 18,
 0352                                Models 1860/1861;       2002.
                                     VENTAK PRIZM VR/DR
                                     Models 1850/1851/1855/
                                     1856; VENTAK PRIZM VR/
                                     DR HE Models 1852/
                                     1853, VENTAK Mini IV
                                     Models 1790/1793/
                                     1796; and VENTAK Mini
                                     III HE Model 1789.
P010039/02M-0336    Siemens         Siemens SONOCUR Basic   July 19,
                     Medical                                 2002.
                     Solutions
                     USA, Inc.
P020003/02M-0322    Mentor Corp.    Mentor Saline-Filled    July 19,
                                     Testicular Prosthesis   2002.
H010004/02M-0361    Guidant Corp.   NEUROLINK System,       August 9,
                                     Including NEUROLINK     2002.
                                     Stent and Delivery
                                     Catheter and
                                     NEUROLINK Balloon
                                     Dilatation Catheter.
P990026(S8)/02M-    Cygnus, Inc.    GlucoWatch G2           August 26,
 0412                                Biographer              2002.
H020002/02M-0409    SMART           Neuroform               September
                     Therapeutics,   Microdelivery Stent     11, 2002.
                     Inc.            System
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: December 24, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-662 Filed 1-10-03; 8:45 am]
BILLING CODE 4160-01-S