67 FR 215 pgs. 67629-67631 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 67Number: 215Pages: 67629 - 67631
Docket number: [Docket Nos. 02M-0250, 02M-0203, 02M-0180, 02M-0218, 02M-0272, 02M-0271, 02M-0145, 02M-0311, 02M-0172, 02M-0217, 02M-0179, 02M-0255, 02M-0173, 02M-0235, 02M-0167, 02M-0174, 02M-0216, and 02M-0236]
FR document: [FR Doc. 02-28155 Filed 11-5-02; 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. 02M-0250, 02M-0203, 02M-0180, 02M-0218, 02M-0272, 02M-0271, 02M-0145, 02M-0311, 02M-0172, 02M-0217, 02M-0179, 02M-0255, 02M-0173, 02M-0235, 02M-0167, 02M-0174, 02M-0216, and 02M-0236]
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 (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Dockets Management Branch.
ADDRESSES:
Submit written requests 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 summaries 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 January 1998, FDA revised 21 CFR 814.44(d) and 814.45(d) (63 FR 4571, January 30, 1998) to discontinue individual publication of PMA approvals and denials in the Federal Register , providing instead to post this information to FDA's home page at http://www.fda.gov on the Internet. In addition, the regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during 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 PMAs for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure described above from April 1, 2002, through June 30, 2002. 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 |
|---|---|---|---|
| P000008/02M-0250 | BioEntrics Corp. | LAP-BAND Adjustable Gastric Banding System | June 5, 2001. |
| P980033/02M-0203 | Boston Scientific Scimed, Inc. | WALLSTENT Endoprosthesis | November 16, 2001. |
| P010027/02M-0180 | Ophthalmic Innovations International, Inc. | ALLERGAN, INC. Model AC 21B Anterior Chamber Intraocular Lens (Cataract) | November 21, 2001. |
| P010033/02M-0218 | Cellestis Ltd. | QUANTIFERON-TB | November 28, 2001. |
| P000049/02M-0272 | Nitinol Medical Technologies, Inc. | CARDIOSEAL Septal Occlusion System With QWIKLOAD | December 5, 2001. |
| P000039/02M-0271 | AGA Medical Corp. | THE AMPLATZER Septal Occluder (ASO) And AMPLATZER Exchange System | December 5, 2001. |
| P010030/02M-0145 | Lifecor, Inc. | Wearable Cardioverter Defibrillator (WCD) 2000 "Lifevest" System | December 18, 2001. |
| H000002/02M-0311 | VISX, Inc. | VISX EXCIMER LASER SYSTEM AND CUSTOM CONTOURED ABLATION PATTERN (C0-CAP) METHOD | December 19, 2001. |
| P980024(S1)/02M-0172 | Vysis | PATHVYSION HER-2 DNA Probe Kit | December 31, 2001. |
| P9600009(S7)/02M-0217 | Medtronic, Inc. | MEDTRONIC ACTIVA Parkinson's Control System | January 14, 2002. |
| P010054/02M-0179 | Roche Diagnostics Co. | ELECSYS ANTI-HBS Immunoassay PRECICONTROL ANTI02M-HBS | February 28, 2002. |
| P000037(S1)/02M-0255 | Medical Carbon Research Institute, LLC | ON-X Prosthetic Heart Valve, Models ONXM and ONXMC | March 6, 2002. |
| P010025/02M-0173 | Hologic, Inc. | LORAD Digital Breast Imager | March 15, 2002. |
| P000033/02M-0235 | SulzerIntra Therapeutics, Inc. | INTRACOIL Self-Expanding Peripheral Stent | April 3, 2002. |
| H000007/02M-0167 | AGA Medical Corp. | AMPLATZER PFO Occluder | April 5, 2002. |
| P010018/02M-0174 | Refractec, Inc. | VIEWPOINT CK SYSTEM | April 11, 2002. |
| P900033(S8)/02M-0216 | Integra Lifesciences, Corp. | INTEGRA Dermal Regeneration Template | April 19, 2002. |
| P010012/02M-0236 | Guidant Corp. | CONTAK CD/EASYTRAK Lead System, Models 4510, 4511, 4512, And 4513 | May 2, 2002. |
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.
Dated: October 23, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28155 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S