Medical devices: Premarket approval applications, list; safety and effectiveness summaries availability,
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Federal Register: April 3, 2007 (Volume 72, Number 63)NoticesPage 15885-15886From 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-0531Medical 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:
I. 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.
II. 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 amBILLING CODE 4160-01-S
