Medical devices: Premarket approval applications, list; safety and effectiveness summaries availability,

[Federal Register: July 6, 2001 (Volume 66, Number 130)]

[Notices]

[Page 35645-35646]

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

[DOCID:fr06jy01-73]

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:

1. 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 LADARVisionNovember 2, 1998 Corp..

   Excimer Laser System. P970025/01M-0072.................. DiaSorin, Inc............. PRO-TRAC IITMTacrolimus 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 YsioTMAS PC Coated September 29, 2000 Cardiovascular, Inc.. Stent and Delivery System. P000022/01M-0039.................. Medtronic AVE, Inc........ AVE BeStentTM2 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..... PhotonTMDR 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..... MicronyTMSR+ 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 JOSTENTJanuary 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).

2. 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. 01-16918Filed7-5-01; 8:45 am]

   BILLING CODE 4160-01-S