Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 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]
 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 
                        ( print 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 § 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 No.
Applicant
Trade Name
Approval DateP040027/2006M-0411
W.L. Gore & Associates
GORE VIATORR TIPS
December 6, 2004P040023/2006M-0512
DePuy Orthopedics, Inc.
DURALOC OPTION CERAMIC HIP SYSTEM
May 3, 2005P030047/2006M-0412
Cordis Corp.
CORDIS PRECISE NITINOL STENT
September 22, 2006P050038/2006M-0396
Medafor, Inc.
ARISTA AH ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
September 26, 2006P970053(S9)/2006M-0460
Nidek, Inc.
NIDEK EC-5000 EXCIMER LASER
October 11, 2006P050022/2006M-0456
Siemens Medical Solutions USA, Inc.
SYNGO LUNG COMPUTER ASSISTED DETECTION (CAD) SYSTEM
October 18, 2006P050025/2006M-0459
Endotex Interventional Systems, Inc.
ENDOTEX NEXSTENT CAROTID STENT & DELIVERY SYSTERM; AND ENDOTEX NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTERM
October 27, 2006P020012/2006M-0455
Artes Medical USA, Inc.
ARTEFILL
October 27, 2006P040050/2006M-0457
Uroplasty, Inc.
MACROPLASTIQUE IMPLANTS
October 30, 2006P050031/2006M-0473
Paragon Vision Sciences
PARAGON Z CRT
November 16, 2006P020056/2006M-0490
Allergan
INAMED SILICONE-FILLED BREAST IMPLANTS
November 17, 2006P030053/2006M-0492
Mentor Corp.
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
November 17, 2006P060010/2006M-0529
AbbeyMoor Medical, Inc.
THE SPANNER TEMPORARY PROSTATIC STENT
December 14, 2006P040025/2006M-0530
Olympic Medical
OLYMPIC COOL-CAP
December 20, 2006P050033/2006M-0531
Anika Therapeutics, Inc.
COSMETIC TISSUE AUGMENTATION PRODUCT
December 20, 2006
 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 am] BILLING CODE 4160-01-S