[Federal Register Volume 66, Number 130 (Friday, July 6, 2001)]
[Notices]
[Pages 35645-35646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16918]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-1592, 01M-0072, 01M-0043, 00M-0014, 00M-0012, 00M-
0011, 01M-0042, 00M-0055, 01M-0039, 00M-0015, 01M-0041, 00M-1683, 00M-
0013, 00M-1684, 01M-0038, 01M-0062, 01M-0149, 01M-0201]


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 summary 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 FDA's Intranet home page 
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 in accordance with 
the procedure explained previously from January 1, 2001, through March 
31, 2001. There were no denial actions during this period. The list 
provides the

[[Page 35646]]

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 January 1, 2001, through
                                                 March 31, 2001
----------------------------------------------------------------------------------------------------------------
        PMA No./Docket No.                   Applicant                  Trade Name              Approval Date
----------------------------------------------------------------------------------------------------------------
P970043/00M-1592..................  Autonomous Technologies     LADARVision       November 2, 1998
                                     Corp..                      Excimer Laser System.
P970025/01M-0072..................  DiaSorin, Inc.............  PRO-TRAC IITM Tacrolimus    April 27, 1999
                                                                 ELISA Kit.
P970049/01M-0043..................  Laser Institute of the      Dishler Excimer Laser       December 16, 1999
                                     Rockies.                    System.
P970053(S2)/00M-0014..............  Nidek Technologies, Inc...  EC 5000 Excimer Laser       April 14, 2000
                                                                 System.
P990074/00M-0012..................  McGhan Medical Corp.......  RTV Saline-Filled Breast    May 10, 2000
                                                                 Implants.
P990075/00M-0011..................  Mentor Corp...............  Saline-Filled and           May 10, 2000
                                                                 Spectrum
                                                                 Mammary Prostheses.
P000009/01M-0042..................  Biotronik, Inc............  Phylax AV Implantable       September 29, 2000
                                                                 Cardioveter Defibrillator
                                                                 with Program Software.
P000011/00M-0055..................  Biocompatibilities          Biodiv YsioTM AS PC Coated  September 29, 2000
                                     Cardiovascular, Inc..       Stent and Delivery System.
P000022/01M-0039..................  Medtronic AVE, Inc........  AVE BeStentTM 2 with        October 16, 2000
                                                                 Discrete TechnologyTM
                                                                 Coronary Stent Delivery
                                                                 System.
P930016(S10)/00M-0015.............  VISX, Inc.................  STAR S2 and S3 Excimer      October 18, 2000
                                                                 Laser System.
P910023(S47)/01M-0041.............  St. Jude Medical, Inc.....  PhotonTM DR Implantable     October 27, 2000
                                                                 Cardioverter
                                                                 Defibrillator (ICD).
P000027/00M-1683..................  Roche Diagnostics Corp....  Elecsys Free Immunoassay    December 12, 2000
                                                                 Calset/Calcheck.
P970013/00M-0013..................  St. Jude Medical, Inc.....  MicronyTM SR+ Model 2425T.  December 21, 2000
P980020/00M-1684..................  Q Care International, LLC.  Q 103 Needle Management     December 21, 2000
                                                                 Systems.
P950021(S2)/01M-0038..............  Bayer Corp................  ACS: 180 and Advia Centaur  December 22, 2000
                                                                 PSA Assays.
H000001/01M-0062..................  JOMED AB..................  JOMED JOSTENT     January 10, 2001
                                                                 Coronary Stent Graft.
P990085/01M-0149..................  VISTAKON (Division of       VISTAKON Soft Contact       February 16, 2001
                                     Johnson & Johnson Vision    Lenses for Extended Wear.
                                     Care, Inc.).
H990013/01M-0201..................  Ortec International, Inc..  Composite Cultured Skin     February 21, 2001
                                                                 (CCS).
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

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

    Dated: June 21, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-16918 Filed 7-5-01; 8:45 am]
BILLING CODE 4160-01-S