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

[Federal Register: May 22, 2002 (Volume 67, Number 99)]

[Notices]

[Page 36009-36011]

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

[DOCID:fr22my02-66]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 01M-0478, 01M-0460, 01M-0454, 01M-0453, 01M-0452, 01M- 0456, 01M-0451, 01M-0455, 01M-0578, 01M-0507, 01M-0579, 01M-0535, 01M- 0462, 01M-0461, 01M-0536, 01M-0520, 01M-0439, 01M-0509, 01M-0490, 01M- 0498, 01M-0479, 01M-0480, 01M-0482, 01M-0508, 01M-0522, 01M-0537, 01M- 0523, 01M-0530, 01M-0531, 01M-0534, 01M-0567, 01M-0581]

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:

1. 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.

   [[Page 36010]]

   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

   Approval No.

   Applicant

   Trade Name

   Date

   P990050/01M- Spectrascience, Optical Biopsy System November 0478

   Inc.

   14, 2000 P000020/01M- C.R. Bard, Inc. Stinger Ablation

   November 0460

   Catheter Templink

   29, 2000 Extension Cable P990043/01M- Diasorin, Inc. DIASORIN ETI-EBK PLUS February 8, 0454

   Assay

   2001 P990042/01M- Diasorin, Inc. DIASORIN ETI-AB-AUK March 30, 0453

   PLUS Assay

   2001 P990041/01M- Diasorin, Inc. DIASORIN ETI-AB-EBK March 30, 0452

   PLUS Assay

   2001 P990045/01M- Diasorin, Inc. DIASORIN ETI-AB-COREK March 30, 0456

   PLUS Assay

   2001 P990038/01M- Diasorin, Inc. DIASORIN ETI MAK-2 PLUS March 30, 0451

   Assay

   2001 P990044/01M- Diasorin, Inc. DIASORIN ETI-CORE IGMK March 30, 0455

   PLUS Assay

   2001 P000040/01M- Bei Medical

   HYDROTHERMABLATOR

   April 20, 0578

   Systems Co., Inc. Endometrial Ablation 2001 System P990012/01M- Roche Diagnostics Elecsys Hbsag

   June 1, 0507

   Corp.

   Immunoassay, Elecsys 2001 Hbsag Confirmatory, and Precicontrol Hbsag P000053/01M- American Medical AMS SPHINCTER 800

   June 14, 0579

   Systems, Inc. Urinary Control System 2001 P930027(S004)/ Diagnostic

   Immulite PSA, Immulite June 19, 01M-0535

   Products Corp. Third Generation PSA, 2001 Immulite 2000 P880086(S083)/ St. Jude Medical, Integrity AFX DR Model July 11, 01M-0462

   Inc.

   5346 Dual Chamber

   2001 Pulse Generator and Programmer Software Model 3307, V2.2a P830045(S076)/ St. Jude Medical, Integrity AFX DR Model July 11, 01M-0461

   Inc.

   5346 Dual Chamber

   2001 Pulse P010021/01M- Ortho-Clinical Vitros Immunodiagnostic August 30, 0536

   Diagnostics, Inc. Products Anti-HCV

   2001 Reagent Pack and Calibrator P890057(S014)/ Sensor Medics Model 3100b High

   September 01M-0520

   Corp.

   Frequency Oscillatory 24, 2001 Ventilator (HFOV) P000029/01M- Q-Med Ab

   Deflux Injectable Gel September 0439

   Ren

   24, 2001 P010017/01M- Fisher Imaging SENOSCAN Full Field September 0509

   Corp.

   Digital Mammagraphy 25, 2001 System P980008(S005)/ Lasersight

   Lasersight Laserscan September 01M-0490

   Technologies, Lsx Excimer Laser

   28, 2001 Inc.

   System For Laser- Assisted In Situ Keratomileusis (LASIK) P000036/01M- Advanced Tissue Dermagraft

   September 0498

   Sciences

   28, 2001 P010019/01M- Ciba Vision Corp. Focus Night And Day October 11, 0479

   (Lotrafilcon A) Soft 2001 Contact Lenses P000030/01M- Ciba Vision Corp. Focus Night & Day

   October 12, 0480

   (Lotrafilcon A) Soft 2001 Contact Lenses H010002/01M- Stryker Biotech OP-1 Implant

   October 17, 0482

   2001 P000052/01M- Guidant Corp. Galileo Intravascular November 2, 0508

   Radiotherapy System 2001 P930016(S014)/ VISX, Inc.

   VISX STAR Excimer Laser November 6, 01M-0522

   System

   2001 P010007/01M- Diagnostic

   Immulite/Immulite 2000 November 9, 0537

   Products Corp. Afp Assays

   2001 P990015/01M- Lifecore

   Intergel Adhesion

   November 0523

   Biomedical, Inc. Prevention Solution 16, 2001 P000057/01M- Ascension

   Ascension Mcp

   November 0530

   Orthopedics, Inc.

   19, 2001 P980006(S004)/ Bausch & Lomb, Purevision (Balafilcon November 01M-0531

   Inc.

   1. Visibility Tinted 20, 2001 Contact Lenses P010032/01M- Advanced

   Genesis

   November 0534

   Neuromodulation Neurostimulation (Ipg) 21, 2001 System, Inc.

   System P010003/01M- Cryolife, Inc. BIOGLUE Surgical

   December 3, 0567

   Adhesive

   2001 P010020/01M- American Medical AMS Acticon

   December 0581

   Systems, Inc. Neosphincter

   18, 2001

   [[Page 36011]]

2. 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.

   [FR Doc. 02-12728Filed5-21-02; 8:45 am]

   BILLING CODE 4160-01-S