[Federal Register: January 13, 2003 (Volume 68, Number 8)]

[Notices]               

[Page 1620-1621]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13ja03-64]                         





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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