02-12728. 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 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 to revise §§ 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 §§ 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 home page at http://www.fda.gov on the Internet, 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 § 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 October 1, 2001, through December 31, 2001. 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 October 1, 2001, through December 31, 2001

PMA No./Docket No.	Applicant	Trade Name	Approval Date
P990050/01M-0478	Spectrascience, Inc.	Optical Biopsy System	November 14, 2000
P000020/01M-0460	C.R. Bard, Inc.	Stinger Ablation Catheter Templink Extension Cable	November 29, 2000
P990043/01M-0454	Diasorin, Inc.	DIASORIN ETI-EBK PLUS Assay	February 8, 2001
P990042/01M-0453	Diasorin, Inc.	DIASORIN ETI-AB-AUK PLUS Assay	March 30, 2001
P990041/01M-0452	Diasorin, Inc.	DIASORIN ETI-AB-EBK PLUS Assay	March 30, 2001
P990045/01M-0456	Diasorin, Inc.	DIASORIN ETI-AB-COREK PLUS Assay	March 30, 2001
P990038/01M-0451	Diasorin, Inc.	DIASORIN ETI MAK-2 PLUS Assay	March 30, 2001
P990044/01M-0455	Diasorin, Inc.	DIASORIN ETI-CORE IGMK PLUS Assay	March 30, 2001
P000040/01M-0578	Bei Medical Systems Co., Inc.	HYDROTHERMABLATOR Endometrial Ablation System	April 20, 2001
P990012/01M-0507	Roche Diagnostics Corp.	Elecsys Hbsag Immunoassay, Elecsys Hbsag Confirmatory, and Precicontrol Hbsag	June 1, 2001
P000053/01M-0579	American Medical Systems, Inc.	AMS SPHINCTER 800 Urinary Control System	June 14, 2001
P930027(S004)/01M-0535	Diagnostic Products Corp.	Immulite PSA, Immulite Third Generation PSA, Immulite 2000	June 19, 2001
P880086(S083)/01M-0462	St. Jude Medical, Inc.	Integrity AFX DR Model 5346 Dual Chamber Pulse Generator and Programmer Software Model 3307, V2.2a	July 11, 2001
P830045(S076)/01M-0461	St. Jude Medical, Inc.	Integrity AFX DR Model 5346 Dual Chamber Pulse	July 11, 2001
P010021/01M-0536	Ortho-Clinical Diagnostics, Inc.	Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator	August 30, 2001
P890057(S014)/01M-0520	Sensor Medics Corp.	Model 3100b High Frequency Oscillatory Ventilator (HFOV)	September 24, 2001
P000029/01M-0439	Q-Med Ab	Deflux Injectable Gel Ren	September 24, 2001
P010017/01M-0509	Fisher Imaging Corp.	SENOSCAN Full Field Digital Mammagraphy System	September 25, 2001
P980008(S005)/01M-0490	Lasersight Technologies, Inc.	Lasersight Laserscan Lsx Excimer Laser System For Laser-Assisted In Situ Keratomileusis (LASIK)	September 28, 2001
P000036/01M-0498	Advanced Tissue Sciences	Dermagraft	September 28, 2001
P010019/01M-0479	Ciba Vision Corp.	Focus Night And Day (Lotrafilcon A) Soft Contact Lenses	October 11, 2001
P000030/01M-0480	Ciba Vision Corp.	Focus Night & Day (Lotrafilcon A) Soft Contact Lenses	October 12, 2001
H010002/01M-0482	Stryker Biotech	OP-1 Implant	October 17, 2001
P000052/01M-0508	Guidant Corp.	Galileo Intravascular Radiotherapy System	November 2, 2001
P930016(S014)/01M-0522	VISX, Inc.	VISX STAR Excimer Laser System	November 6, 2001
P010007/01M-0537	Diagnostic Products Corp.	Immulite/Immulite 2000 Afp Assays	November 9, 2001
P990015/01M-0523	Lifecore Biomedical, Inc.	Intergel Adhesion Prevention Solution	November 16, 2001
P000057/01M-0530	Ascension Orthopedics, Inc.	Ascension Mcp	November 19, 2001
P980006(S004)/01M-0531	Bausch & Lomb, Inc.	Purevision (Balafilcon A) Visibility Tinted Contact Lenses	November 20, 2001
P010032/01M-0534	Advanced Neuromodulation System, Inc.	Genesis Neurostimulation (Ipg) System	November 21, 2001
P010003/01M-0567	Cryolife, Inc.	BIOGLUE Surgical Adhesive	December 3, 2001
P010020/01M-0581	American Medical Systems, Inc.	AMS Acticon Neosphincter	December 18, 2001

II. Electronic Access

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

Dated: May 10, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.