65 FR 242 pgs. 78495-78496 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 65Number: 242Pages: 78495 - 78496
Docket number: [Docket Nos. 00M-1391, 00M-1536, 00M-1447, 00M-1522, 00M-0809, 00M-1517, 00M-1451, 00M-1448, 00M-1507, 00M-1389, 00M-1388, 00M-1508, 00M-1390, 00M-1386, 00M-1387, 00M-1414, 00M-1415, 00M-1416, 00M-1495, 00M-1437, 00M-1475, 00M-1483, 00M-1515, 00M-1524, 00M-1523]
FR document: [FR Doc. 00-31960 Filed 12-14-00; 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-1391, 00M-1536, 00M-1447, 00M-1522, 00M-0809, 00M-1517, 00M-1451, 00M-1448, 00M-1507, 00M-1389, 00M-1388, 00M-1508, 00M-1390, 00M-1386, 00M-1387, 00M-1414, 00M-1415, 00M-1416, 00M-1495, 00M-1437, 00M-1475, 00M-1483, 00M-1515, 00M-1524, 00M-1523]
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 as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summary 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:
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 July 1, 2000, through September 30, 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 |
|---|---|---|---|
| P930016(S7)/00M-1391 | VISX, Inc. | VISX STAR S2 Excimer Laser System | November 2, 1998 |
| P920030(S2)/00M-1536 | Chiron Corp. | CIBA Corning ACS PSA Immunoassay | December 8, 1998 |
| P910065(S1)/00M-1523 | Tosoh Medics, Inc. | AIA-PACK PA | September 10, 1999 |
| P990010/00M-1447 | CRS Clinical Research, Inc. | VISX Inc. Excimer Laser System Model C "STAR" | November 19, 1999 |
| P940035(S2)/00M-1522 | Matritech Inc. | Matritech NMP22® Test Kit | January 18, 2000 |
| P990023/00M-0809 | Alcon Laboratories | Cellugel® Ophthalmic Viscosurgical Device | February 24, 2000 |
| P990054/00M-1517 | Cardiac Pathways Corp. | Chilli® Cooled Ablation System | March 17, 2000 |
| H990014/00M-1451 | Medtronic Inc. | Enterra TM Therapy System (formerly named Gastric Electrical Stimulation (GES) System) | March 31, 2000 |
| P990053/00M-1448 | Nellcor Puritan Bennett | OxiFirst® Fetal Oxygen Saturation Monitoring System | May 12, 2000 |
| P990028/00M-1507 | Focal, Inc. | Focal Seal-L Synthetic Absorbable Sealant | May 26, 2000 |
| P980050/00M-1389 | Medtronic Inc. | Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter Defibrillator | June 14, 2000 |
| P990025/00M-1388 | Biosense Webster, Inc. | NAVI-STAR Diagnostic/Ablation Deflectable Tip Catheter | June 15, 2000 |
| P950032(S16)/00M-1508 | Organogenesis, Inc. | Apligraf (Graftskin) | June 20, 2000 |
| P99037/00M-1390 | Vascular Solutions, Inc. | Vascular Solutions Duett Sealing Device | June 22, 2000 |
| P990078/00M-1386 | Sunrise Technologies | Hyperion LTK System | June 30, 2000 |
| P990021/00M-1387 | QLT Photo Therapeutics, Inc. | Diomed 630 PDT Laser, Model T2USA | June 30, 2000 |
| P990018/00M-1414 | Menicon USA, Inc. | Menicon TM Z Rigid Gas Permeable Contact Lens | July 11, 2000 |
| P000006/00M-1415 | Mentor Corp. | Alpha 1 Inflatable Penile Prosthesis | July 14, 2000 |
| P990064/00M-1416 | Medtronic Inc. | Mosaic® Porcine Bioprosthesic Heart Valve | July 14, 2000 |
| P990034/00M-1495 | Medtronic Inc. | Medtronic® IsoMed® Constant Flow Infusion System | July 21, 2000 |
| P990039/00M-1437 | Metra Biosystems, Inc. | QUS-2 TM Calcaneal Ultrasonometer | August 1, 2000 |
| P990072/00M-1475 | Westcon Contact Lens Co., Inc. | W-55 (Methafilcon A) and Horizon 55 Soft Extended Wear Contact Lenses | August 22, 2000 |
| P860057(S11)/00M-1483 | Edwards Lifesciences, LLC | Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | August 28, 2000 |
| P970042/00M-1515 | Medstone International, Inc. | Medstone STS TM Lithotripter | September 5, 2000 |
| P990055/00M-1524 | Bayer Corp. | Bayer Immuno 1 TM Complexed PSA Assay | September 8, 2000 |
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.
Dated: December 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and Radiological Health.
[FR Doc. 00-31960 Filed 12-14-00; 8:45 am]
BILLING CODE 4160-01-F