Medical devices: Premarket approval applications, list; safety and effectiveness summaries availability,

[Federal Register: December 19, 2007 (Volume 72, Number 243)]

[Notices]

[Page 71922]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19de07-80]

[[Page 71922]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2007M-0285, 2007M-0286, 2007M-0287, 2007M-0288, 2007M- 0289, 2007M-0298, 2007M-0303, 2007M-0344]

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 data 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: Samie Allen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013.

SUPPLEMENTARY INFORMATION:

1. Background

   In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that 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 on the Internet on FDA's home page at http://www.fda.gov. 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 Sec. 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 July 1, 2007, through September 30, 2007. 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.

   Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2007, through September 30, 2007

   PMA No./Docket

   Approval No.

   Applicant

   Trade Name

   Date

   P040044(S1)/ Access Closure, MYNX VASCULAR CLOSURE May 16, 2007M-0285 Inc.

   DEVICE

   2007

   P050016/2007M- Corin, USA

   CORMET HIP RESURFACING July 3, 0286

   SYSTEM

   2007

   P050039/2007M- Exactech, Inc. NOVATION CERAMIC

   July 5, 0287

   ARTICULATION HIP SYSTEM 2007

   P930016(S25)/ VISX, Inc.

   STAR S4 IR EXCIMER LASER July 11, 2007M-0288

   SYSTEM & WAVESCAN

   2007 SYSTEM

   P060018/2007M- Medtronic Sofamor PRESTIGE CERVICAL DISC July 16, 0289

   Danek, Inc.

   SYSTEM

   2007

   P060002/2007M- C.R. Bard, Inc. FLAIR ENDOVASCULAR STENT July 23, 0298

   GRAFT

   2007

   P050024/2007M- Cryocor, Inc. CRYOCOR CRYOABLATION August 1, 0303

   SYSTEM

   2007

   P050043/2007M- Morris Innovative FEMORAL INTRODUCER

   August 20, 0344

   Research, Inc. SHEATH & HEMOSTASIS 2007 (FISH) DEVICE 5, 6, & 8 FRENCH

2. Electronic Access

   Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.

   Dated: December 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy.

   [FR Doc. E7-24620 Filed 12-18-07; 8:45 am]

   BILLING CODE 4160-01-S