00-14702. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
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Start Preamble
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
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 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 § 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.
Start SignatureTable 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 #KEA940202) July 30, 1998 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 Cardiovascular Defibrillator September 15, 1999 H990003/99M-4619 American Medical Systems ActiconTM Neosphincter September 20, 1999 Start Printed Page 36818 P850022(S9)/00M-0901 Biolectron Inc. SpinalPak® Stimulator September 24, 1999 H990005/99M-4763 Nitinol Medical Technologies CardioSEAL® Septal Occlusion System September 28, 1999 P930034(S12)/00M-0424 Summit Technology SVS Apex Plus Excimer Laser Workstation w/the Emphasis Discs October 21, 1999 P910066(S11)/00M-1073 Orthologic Corp. OrthologicTM 1000 Bone Growth Stimulator December 17, 1999 P990035/00M-0577 Sunlight Ultrasound Technologies, Ltd. The SunlightTM Omnisense Ultrasound Bone Sonometer January 20, 2000 P990066/00M-0579 GE Medical Systems Senographe 2000D January 28, 2000 H990011/00M-0599 Nitinol Medical Technologies CardioSEAL® Septal Occlusion System February 1, 2000 P980040/00M-0445 Allergan Inc. Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens February 3, 2000 P990016/00M-0580 McCue Corporation, Inc. McCue CUBAClinical Ultraonic Bone Sonometry System w/CUBAplus+V4.1.0 February 15, 2000 P940034(S8)/00M-0578 Gen-Probe Incorporated Gen-Probe® AmplifiedTM Mycobacterium Tuberculosis Direct (MTD) Test February 15, 2000 P900009(S6)/00M-0810 Smith & Nephew Inc. Exogen 2000 or Sonic Accelerated Fracture Healing System February 22, 2000 P990023/00M-0809 Alcon Labs Cellugel® Ophthalmic Viscosurgical Device February 24, 2000 P950019(S9)/00M-1212 United States Surgical Corp. Ray Threaded Fusion Cage (TFC) w/Instrumentation March 2, 2000 Dated: May 23, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and Radiological Health.
[FR Doc. 00-14702 Filed 6-9-00; 8:45 am]
BILLING CODE 4160-01-F
Document Information
- Published:
- 06/12/2000
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 00-14702
- Pages:
- 36817-36818 (2 pages)
- Docket Numbers:
- 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
- PDF File:
- 00-14702.pdf