68 FR 215 pgs. 62812-62813 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 68Number: 215Pages: 62812 - 62813
Docket number: [Docket Nos. 2003M-0287, 2003M-0271, 2003M-0272, 2003M-0262, 2003M-0175, 2003M-0240, 2003M-0189, 2003M-0241, 2003M-0332, 2003M-0337, 2003M-0174, 2003M-0173, 2003M-0190, 2003M-0343, 2003M-0242, 2003M-0333, 2003M-0339, 2003M-0320, 2003M-0352, 2003M-0157]
FR document: [FR Doc. 03-27882 Filed 11-5-03; 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. 2003M-0287, 2003M-0271, 2003M-0272, 2003M-0262, 2003M-0175, 2003M-0240, 2003M-0189, 2003M-0241, 2003M-0332, 2003M-0337, 2003M-0174, 2003M-0173, 2003M-0190, 2003M-0343, 2003M-0242, 2003M-0333, 2003M-0339, 2003M-0320, 2003M-0352, 2003M-0157]
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 Division of Dockets Management.
ADDRESSES:
Submit written requests for copies of summaries of safety and effectiveness to the Division of Dockets Management (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 the Federal Register January 30, 1998 (63 FR 4571), FDA revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register . Instead, the agency now posts this information to FDA's home page at http://www.fda.gov on the Internet. 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 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. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from April 1, 2003, through June 30, 2003. 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 No./Docket No. | Applicant | Trade Name | Approval Date |
|---|---|---|---|
| P010052/2003M-0287 | Diagnostic Products Corp. | Immulite/Immulite 2000 Anti-HBS | July 22, 2002 |
| P010051/2003M-0271 | Diagnostic Products Corp. | Immulite/Immulite 2000 Anti-HBC | July 24, 2002 |
| P010053/2003M-0272 | Diagnostic Products Corp. | Immulite/Immulite 2000 Anti-HBC IGM | July 26, 2002 |
| P010050/2003M-0262 | Diagnostic Products Corp. | Immulite/Immulite 2000 HBSAF and Immulite HBSAF Confirmatory Kit | July 26, 2002 |
| P020014/2003M-0175 | Conceptus, Inc. | Essure System | November 4, 2002 |
| P990069/2003M-0240 | EpMed Systems, Inc. | Alert System (Alert Catheter, Alert Interface Cable, and Alert Companion With Software Version 1.08) | November 27, 2002 |
| P010055/2003M-0189 | Prostalund Operations AB | Prostalund Coretherm System Microwave Thermotherapy for BPH | December 23, 2002 |
| P020028/2003M-0241 | Philips Medical System | Series 50 XMO (Model M1350C) Fetal/Maternal Monitor System With Integrated Fetal Oxygen Saturation Monitoring | January 3, 2003 |
| P990027(S004)/2003M-0174 | Bausch Lomb Surgical, Inc. | Technolas 217A Excimer Laser System | February 25, 2003 |
| P990086(S003)/2003M-0173 | Health Tronics Surgical Services, Inc. | Healthtronics Ossatron | March 14, 2003 |
| P980035(S013)/2003M-0190 | Medtronic, Inc. | Medtronic AT500 DDDRP Pacing System (Model A1501) and Model 9968 Software | March 27, 2003 |
| H020007/2003M-0157 | Medtronic Neurological | Medtronic Activa Dystonia Therapy | April 15, 2003 |
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II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html .
Dated: October 20, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27882 Filed 11-5-03; 8:45 am]
BILLING CODE 4160-01-S