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

[Federal Register: June 12, 2000 (Volume 65, Number 113)]

[Notices]

[Page 36817-36818]

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

[DOCID:fr12jn00-33]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-0811, 00M-1215, 00M-1216, 00M-0915, 99M-4619, 00M- 0901, 99M-4763, 00M-0424, 00M-1073, 00M-0577, 00M-0579, 00M-0599, 00M- 0445, 00M-0580, 00M-0578, 00M-0810, 00M-0809, 00M-1212]

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 (PMA's) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMA's through the Internet and the agency's Dockets Management Branch.

ADDRESSES: Summaries of safety and effectiveness are available on the Internet at http://www.fda.gov/cdrh/pmapage.html. Copies of summaries of safety and effectiveness are also available by submitting a written request 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 in the SUPPLEMENTARY INFORMATION section of this document when submitting a written request.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION: 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 Internet 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 PMA's 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)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), 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 PMA's for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure explained previously from January 1, 2000, through March 31, 2000. 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 PMA's Made Available January 1, 2000, through March 31, 2000

PMA Number/Docket No.

Applicant

Trade Name

Approval Date

P970005/00M-0811

Kremer Laser Eye Center

Kremer Exciber Laser System (Serial

July 30, 1998 #KEA940202) P970055/00M-1215

Biotrin International, Ltd.

Biotrin Parvovirus IgM EIA (V619IMUS)

August 6, 1999 P970054/00M-1216

Biotrin International, Ltd.

Biotrin Parvovirus IgG EIA (V519IGUS)

August 6, 1999 P980049/00M-0915

ELA Medical, Inc.

Defender II Model 9201 Implantable

September 15, 1999 Cardiovascular Defibrillator H990003/99M-4619

American Medical Systems

ActiconTMNeosphincter

September 20, 1999

[[Page 36818]]

P850022(S9)/00M-0901

Biolectron Inc.

SpinalPakStimulator

September 24, 1999 H990005/99M-4763

Nitinol Medical Technologies

CardioSEALSeptal Occlusion System September 28, 1999 P930034(S12)/00M-0424

Summit Technology

SVS Apex Plus Excimer Laser Workstation w/the October 21, 1999 Emphasis Discs P910066(S11)/00M-1073

Orthologic Corp.

OrthologicTM1000 Bone Growth Stimulator December 17, 1999 P990035/00M-0577

Sunlight Ultrasound Technologies, The SunlightTMOmnisense Ultrasound Bone January 20, 2000 Ltd.

Sonometer P990066/00M-0579

GE Medical Systems

Senographe 2000D

January 28, 2000 H990011/00M-0599

Nitinol Medical Technologies

CardioSEALSeptal Occlusion System February 1, 2000 P980040/00M-0445

Allergan Inc.

Sensar Soft Acrylic UV-Light Absorbing

February 3, 2000 Posterior Chamber Intraocular Lens P990016/00M-0580

McCue Corporation, Inc.

McCue CUBAClinical Ultraonic Bone Sonometry February 15, 2000 System w/CUBAplus+V4.1.0 P940034(S8)/00M-0578

Gen-Probe Incorporated

Gen-ProbeAmplifiedTMMycobacterium February 15, 2000 Tuberculosis Direct (MTD) Test P900009(S6)/00M-0810

Smith & Nephew Inc.

Exogen 2000 or Sonic Accelerated Fracture February 22, 2000 Healing System P990023/00M-0809

Alcon Labs

CellugelOphthalmic Viscosurgical February 24, 2000 Device P950019(S9)/00M-1212

United States Surgical Corp.

Ray Threaded Fusion Cage (TFC) w/

March 2, 2000 Instrumentation

Dated: May 23, 2000. Linda S. Kahan, Deputy Director for Regulations Policy, Center for Devices and Radiological Health.

[FR Doc. 00-14702Filed6-9-00; 8:45 am]

BILLING CODE 4160-01-F