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 Department of Health and Human Services Food and Drug Administration [Docket Nos. FDA-2009-M-0033, FDA-2009-M-0016, FDA-2009-M-0034, FDA-2009-M-0049, FDA-2009-M-0071, FDA-2009-M-0127, FDA-2009-M-0128, FDA-2009-M-0135, FDA-2009-M-0159]
 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 data 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: Nicole Wolanski, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301-796-6570.


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 
                    ( print page 51289)
                    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 January 1, 2009, through March 31, 2009. 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 January 1, 2009, through March 31, 2009**
PMA No.
                             Docket No.
Applicant
Trade Name
Approval DateP060030
                             FDA-2009-M-0033
Roche Molecular Systems, Inc.
Cobas ampliprep/cobas taqman HFC test
October 30, 2008P950009 (S8)
                             FDA-2009-M-0016
BD Diagnostics
BD focal point gs imaging system
December 3, 2008P080010
                             FDA-2009-M-0034
Advanced Medical Optics, Inc.
Tecnis multifocal foldable posterior chamber intraocular lens
January 16, 2009P080021
                             FDA-2009-M-0049
Advanced Vision Science, Inc.
xact foldable hydrophobic acrylic UV light absorbing posterior chamber IOL
February 2, 2009P030031 (S11)
                             FDA-2009-M-0071
Biosense Webster, Inc.
Navistar & Celsius thermo cool catheters
February 6, 2009P070014
                             FDA-2009-M-0127
Bard Peripheral Vascular, Inc.
lifestent flexstar & flexstar XL vascular stent system
February 13, 2009P940015 (S12)
                             FDA-2009-M-0128
Genzyme Corp.
Synvisc-One
February 26, 2009P070005
                             FDA-2009-M-0135
Synthemed Corp.
Repel-cv bioresorbable adhesion barrier
March 6, 2009P080002
                             FDA-2009-M-0159
The Female Health Co.
FC2 female condom
March 10, 2009
 II. Electronic Access Persons with access to the Internet may obtain the documents at 
                    *http://www.fda.gov/​cdrh/​pmapage.html.* Dated: September 24, 2009. Jeffrey Shuren, Acting Director, Center for Devices and Radiological Health.


[FR Doc. E9-23962 Filed 10-5-09; 8:45 am] BILLING CODE 4160-01-S