Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 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 Date 

P060030 

FDA–2009–M–0033 

Roche Molecular Systems, Inc. Cobas ampliprep/cobas taqman HFC 

test 

October 30, 2008 

P950009 (S8) 

FDA–2009–M–0016 

BD Diagnostics BD focal point gs imaging system December 3, 2008 

P080010 

FDA–2009–M–0034 

Advanced Medical Optics, Inc. Tecnis multifocal foldable posterior 

chamber intraocular lens 

January 16, 2009 

P080021 

FDA–2009–M–0049 

Advanced Vision Science, Inc. xact foldable hydrophobic acrylic UV 

light absorbing posterior chamber IOL 

February 2, 2009 

P030031 (S11) 

FDA–2009–M–0071 

Biosense Webster, Inc. Navistar & Celsius thermo cool catheters February 6, 2009 

P070014 

FDA–2009–M–0127 

Bard Peripheral Vascular, Inc. lifestent flexstar & flexstar XL vascular 

stent system 

February 13, 2009 

P940015 (S12) 

FDA–2009–M–0128 

Genzyme Corp. Synvisc-One February 26, 2009 

P070005 

FDA–2009–M–0135 

Synthemed Corp. Repel-cv bioresorbable adhesion barrier March 6, 2009 

P080002 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Dental and Craniofacial Research Special 

Emphasis Panel; Review of P01 applications 

on Interdisciplinary Research on Oral 

Manifestations of HIV/AIDS in Vulnerable 

Populations. 

Date: November 12, 2009. 

Time: 9 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Victor Henriquez, PhD, 

Scientific Review Officer, DEA/SRB/NIDCR, 

6701 Democracy Blvd., Room 668, Bethesda, 

MD 20892–4878, 301–451–2405, 

henriquv@nidcr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: September 29, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23997 Filed 10–5–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 


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