66 FR 48 pgs. 14390-14391 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 66Number: 48Pages: 14390 - 14391
Docket number: [Docket Nos. 00M-1640, 00M-1664, 00M-1591, 00M-1613, 00M-1597, 00M-1593, 00M-1583, 00M-1615, 00M-1612, 00M-1569, 00M-1658, 00M-1570, 00M-1616, 00M-1659, 00M-1649, 00M-1650, 00M-1660, 00M-1661, 00M-1683, 00M-1684]
FR document: [FR Doc. 01-5954 Filed 3-9-01; 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-1640, 00M-1664, 00M-1591, 00M-1613, 00M-1597, 00M-1593, 00M-1583, 00M-1615, 00M-1612, 00M-1569, 00M-1658, 00M-1570, 00M-1616, 00M-1659, 00M-1649, 00M-1650, 00M-1660, 00M-1661, 00M-1683, 00M-1684]
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:
Submit a written request 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 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 X. 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 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)(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 PMA's for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure explained previously from October 1, 2000, through December 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 |
|---|---|---|---|
| P970053/00M-1640 | Nidek Technologies, Inc. | EC-5000 Excimer Laser System | December 17, 1998 |
| P970053(S1)/00M-1664 | Nidek Technologies, Inc. | EC-5000 Excimer Laser System (PARK) | September 29, 1999 |
| P930034(S13)/00M-1591 | Summit Technologies | SVS Apex Plus Excimer Laser Workstation | October 21, 1999 |
| P990019/00M-1613 | DUSA Pharmaceuticals, Inc. | BLU-U Light Photodynamic Therapy Illuminator | December 3, 1999 |
| P990027/00M-1597 | Bausch Lomb Surgical, Inc. | Technolas® 217 Excimer Laser System | February 23, 2000 |
| P970043(S5)/00M-1593 | Autonomous Technologies Corp. | LADAR Vision® Excimer Laser System | May 9, 2000 |
| P990052/00M-1583 | Symphonix Devices, Inc. | Vibrant P/Vibrant D Soundbridge System | August 31, 2000 |
| P980010/00M-1615 | Osteometer MediTech, Inc. | DTU-One Ultrasound Scanner | September 19, 2000 |
| P970043(S7)/00M-1612 | Autonomous Technologies Corp. | LADAR Vision® Excimer Laser System | September 22, 2000 |
| P990040/00M-1569 | Cordis Neurovascular, Inc. | Trufill N-Butyl Cyanoacrylate Liquid Embolic System | September 25, 2000 |
| P000014/00M-1658 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Anti-HBS Reagent Pack and Calibrators | September 29, 1999 |
| P990046/00M-1570 | ATS Medical, Inc. | ATS Open Pivot® Bileaflet Heart Valve | October 13, 2000 |
| N18286(S12)/00M-1616 | Pharmacia Upjohn Co. | Gelfoam® Sterile Powder | October 16, 2000 |
| P000015/00M-1659 | Cochlear Corp. | Nucleus 24 Auditory Brainstem Implant (ABI) System | October 20, 2000 |
| P000018/00M-1649 | Novoste Corp. | Beta-Cath TM System | November 3, 2000 |
| P990036/00M-1650 | Cordis Corp. | Cordis Checkmate TM System | November 3, 2000 |
| P990056/00M-1660 | Roche Diagnostics, Corp. | Elecsys® Total PSA Immunoassay and Calset | November 22, 2000 |
| P990081/00M-1661 | Ventana Medical Systems, Inc. | Pathway TM HER 2 | November 28, 2000 |
| P000027/00M-1683 | Roche Diagnostics Corp. | Elecsys® Free PSA Immunoassay/Calset/Calcheck | December 12, 2000 |
| P980020/00M-1684 | Q Care International, LLC | Q-103 Needle Management Systems | December 21, 2000 |
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.
Dated: March 1, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and Radiological Health.
[FR Doc. 01-5954 Filed 3-9-01; 8:45 am]
BILLING CODE 4160-01-F