E7-1199. 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, 240-276-4010, 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 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 § 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, 2006, through September 30, 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 July 1, 2006, through September 30, 2006

PMA No./Docket No.	Applicant	Trade Name	Approval Date
P030019/2006M-0339	Anika Therapeutics, Inc.	ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN	February 4, 2004
P010029/2006M-0338	Ferring Pharmaceuticals, Inc./applicant at approval was Savient Pharmaceuticals, Inc.	NUFLEXXA (1% SODIUM HYALURONATE)	December 3, 2004
P030016/2006M-0340	Staar Surgical Co.	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	December 22, 2005
P970043(S20)/2006M-0323	Alcon Laboratories, Inc.	LADARVISION 4000 EXCIMER LASER SYSTEM	May 1, 2006
P970043(S22)/2006M-0324	Alcon Laboratories, Inc.	LADARVISION 4000 EXCIMER LASER SYSTEM	May 2, 2006
P050051/2006M-0321	Abbott Laboratories, Inc.	ABBOTT ARCHITECT AUSA-B	June 1, 2006
P050042/2006M-0389	Abbott Laboratories, Inc.	ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; AND ARCHITECT ANTI-HCV CONTROL	June 7, 2006
P050044/2006M-0293	Orthovita, Inc.	VITAGEL SURGICAL HEMOSTAT	June 16, 2006
P050017/2006M-0294	Cook Incorporated	ZILVER VASCULAR STENT	June 26, 2006
P050014/2006M-0295	Fujifilm Medical System USA, Inc.	FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)	July 10, 2006
P020050(S4)/2006M-0325	Wavelight AG/applicant at approval was SurgiVision Regulatory Consultants, Inc.	WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM	July 26, 2006
P050011/2006M-0322	Baxter Healthcare Corp./applicant at approval was Innovata PLC	ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION	July 28, 2006
P050023/2006M-0367	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID PACING LEAD	August 10, 2006
P040036/2006M-0374	Biosense Webster, Inc.	NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC ABLATION CATHETER	August 11, 2006
P060004/2006M-0342	Carl Zeiss, Inc./applicant at approval was Carl Zeiss Meditec, Inc.	MEL 80 EXCIMER LASER	August 11, 2006
P050006/2006M-0341	WL Gore & Associates, Inc.	GORE HELEX SEPTAL OCCLUDER	August 11, 2006
P050010/2006M-0343	Synthes Spine/applicant at approval was Synthes Spine Co., L.P.	PRODISC-L TOTAL DISC REPLACEMENT	August 14, 2006
H040006/2006M-0368	Abiomed, Inc.	ABICOR IMPLANTABLE REPLACEMENT HEART	September 5, 2006

II. Electronic Access

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

Dated: January 16, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.