65 FR 112 pgs. 36817-36818 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 65Number: 112Pages: 36817 - 36818
Docket number: [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]
FR document: [FR Doc. 00-14702 Filed 6-9-00; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 §§ 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.
| 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 | Acticon TM Neosphincter | September 20, 1999 |
| 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. | Orthologic TM 1000 Bone Growth Stimulator | December 17, 1999 |
| P990035/00M-0577 | Sunlight Ultrasound Technologies, Ltd. | The Sunlight TM 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® Amplified TM 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