Federal Register: March 17, 2006 (Volume 71, Number 52)
DOCID: FR Doc E6-3850
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
ACTION: Medical devices:
DOCUMENT ACTION: Notice.
[Docket Nos. 2005M-0435, 2005M-0475, 2005M-0473, 2005M-0478, 2005M- 0454, 2005M-0399, 2005M-0477, 2005M-0476, 2005M-0492, 2005M-0474, 2005M-0504]
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.
Premarket approval applications, list; safety and effectiveness summaries’ availability,
DOCUMENT BODY 2:
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
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 October 1, 2005 through December 31, 2005. 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, 2005 through December 31, 2005 PMA No./Docket
No. Applicant Trade Name Approval Date P960040(S28)/ Guidant CRM Corp. VENTAK PRIZM AVT March 27, 2003 2005M0435 AICD SYSTEM
P020045/2005M CryoCath 7F FREEZOR April 17, 2003 0475 Technologies, CARDIAC
P040003/2005M InSightecNorth EXABLATE 2000 October 22, 2004 0473 America SYSTEM
P030056/2005M Bayer Healthcare, ADVIA CENTAUR December 22, 0478 LLC HCV READY PACK 2004 REAGENTS, ADVIA
P980022(S11)/ Medtronic MiniMed GUARDIAN RT July 18, 2005 2005M0454 CONTINUOUS
P020016/2005M Walter Lorenz TOTAL September 21, 0399 Surgical, Inc. TEMPOMANDIBULAR 2005 JOINT
P040047/2005M Bioform Medical, COAPTITE November 10, 0477 Inc. 2005 P040042/2005M Irvine THERAPY DUAL 8 November 18, 0476 Biomedical, Inc. CARDIAC 2005 ABLATION SYSTEM
P030054(S10)/ St. Jude Medical EPIC & ATLAS + November 18, 2005M0492 CRMD HF CRTD 2005 SYSTEMS
P040013/2005M Biomimetic GEM 21S (GROWTH November 18, 0474 Therapeutics, FACTOR ENHANCED 2005 Inc. MATRIX)
P040045/2005M Vistakon, VISTAKON December 20, 0504 Division of (SENOFILCON A) 2005 Johnson & CONTACT LENS,
Johnson Vision CLEAR AND
Care, Inc. VISIBILITY
TINTED WITH UV
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.
Dated: March 7, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health. [FR Doc. E63850 Filed 31606; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Thinh Nguyen, Center for Devices and Radiological Health (HFZ402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 3015942186 ext. 152.