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

[Federal Register: April 3, 2007 (Volume 72, Number 63)]

[Notices]

[Page 15885-15886]

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

[DOCID:fr03ap07-60]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006M-0411, 2006M-0512, 2006M-0412, 2006M-0396, 2006M- 0460, 2006M-0456, 2006M-0459, 2006M-0455, 2006M-0457, 2006M-0473, 2006M-0490, 2006M-0492, 2006M-0529, 2006M-0530 and 2006M-0531]

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

[[Page 15886]]

Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.

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 Web site 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 October 1, 2006, through December 31, 2006. 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 October 1, 2006, through December 31, 2006.

   PMA No./Docket

   Approval No.

   Applicant

   Trade Name

   Date

   P040027/2006M- W.L. Gore & GORE VIATORR TIPS

   December 6, 0411

   Associates

   2004

   P040023/2006M- DePuy

   DURALOC OPTION CERAMIC HIP May 3, 2005 0512

   Orthopedics, SYSTEM Inc.

   P030047/2006M- Cordis Corp. CORDIS PRECISE NITINOL September 0412

   STENT

   22, 2006

   P050038/2006M- Medafor, Inc. ARISTA AH ABSORBABLE

   September 0396

   HEMOSTATIC, NON-COLLAGEN 26, 2006 BASED

   P970053(S9)/ Nidek, Inc. NIDEK EC-5000 EXCIMER October 11, 2006M-0460

   LASER

   2006

   P050022/2006M- Siemens

   SYNGO LUNG COMPUTER

   October 18, 0456

   Medical

   ASSISTED DETECTION (CAD) 2006 Solutions SYSTEM USA, Inc.

   P050025/2006M- Endotex

   ENDOTEX NEXSTENT CAROTID October 27, 0459

   Interventiona STENT & DELIVERY SYSTERM; 2006 l Systems, AND ENDOTEX NEXSTENT Inc.

   CAROTID STENT & MONORAIL DELIVERY SYSTERM

   P020012/2006M- Artes Medical ARTEFILL

   October 27, 0455

   USA, Inc.

   2006

   P040050/2006M- Uroplasty, MACROPLASTIQUE IMPLANTS October 30, 0457

   Inc.

   2006

   P050031/2006M- Paragon Vision PARAGON Z CRT

   November 0473

   Sciences

   16, 2006

   P020056/2006M- Allergan

   INAMED SILICONE-FILLED November 0490

   BREAST IMPLANTS

   17, 2006

   P030053/2006M- Mentor Corp. MENTOR MEMORYGEL SILICONE November 0492

   GEL-FILLED BREAST

   17, 2006 IMPLANTS

   P060010/2006M- AbbeyMoor THE SPANNER TEMPORARY December 0529

   Medical, Inc. PROSTATIC STENT

   14, 2006

   P040025/2006M- Olympic

   OLYMPIC COOL-CAP

   December 0530

   Medical

   20, 2006

   P050033/2006M- Anika

   COSMETIC TISSUE

   December 0531

   Therapeutics, AUGMENTATION PRODUCT

   20, 2006 Inc.

2. Electronic Access

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

   Dated: March 22, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health.

   [FR Doc. E7-6166 Filed 4-2-07; 8:45 am]

   BILLING CODE 4160-01-S