Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 31965-31966 [2011-13692]

Download as PDF Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Notices Mr. Eskinder Negash, Director, Office of Refugee Resettlement, Administration for Children and Families, 901 D Street, SW., Washington, DC 20047. Telephone: 202–401–5388. E-mail: Eskinder.Negash@acf.hhs.gov. FOR FURTHER INFORMATION CONTACT: Dated: May 25, 2011. Eskinder Negash, Director, Office of Refugee Resettlement. [FR Doc. 2011–13677 Filed 6–1–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–M–0034, FDA– 2011–M–0040, FDA–2011–M–0041, FDA– 2011–M–0039, FDA–2011–M–0035, FDA– 2011–M–0056, FDA–2011–M–0105, FDA– 2011–M–0131, FDA–2011–M–0132, FDA– 2011–M–0170, FDA–2011–M–0175, and FDA–2011–M–0198] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This SUMMARY: 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993–0002, 301–796–6570. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that amended 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 https://www.fda.gov. 31965 In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 FD&C 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 January 1, 2011, through March 31, 2011. 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, 2011, THROUGH MARCH 31, 2011 PMA No. Docket No. Applicant Trade name Approval date P010012 (S230) .................... Boston Scientific Corp ......... BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS. September 16, 2010. FDA–2011–M–0034 P100021 ................................ Medtronic Vascular .............. MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM. December 16, 2010. FDA–2011–M–0040 P100010 ................................ FDA–2011–M–0041 P070014 (S10) ...................... Medtronic Cryocath, LP ....... ARCTIC FRONT CRYOCATHETER SYSTEM ................. December 17, 2010. Bard Peripheral Vascular .... LIFESTENT AND LIFESTENT LX VASCULAR STENT SYSTEMS. December 23, 2010. Depuy, Inc ........................... CERAMAX CERAMIC HIP SYSTEM ................................ December 23, 2010. Cook Medical, Inc ................ FORMULA BALLOON–EXPANDABLE RENAL STENT SYSTEM. January 14, 2011. Medtronic, Inc ...................... REVO MRI SURESCAN IPG AND PACING SYSTEM ..... February 8, 2011. Hologic, Inc .......................... SELENIA DIMENSIONS 3D SYSTEMS ............................ February 11, 2011. OraSure Technologies, Inc .. ORAQUICK HCV RAPID ANTIBODY TEST ..................... February 18, 2011. Elana, Inc ............................. ELANA SURGICAL KIT HUD ............................................ March 10, 2011. Medtronic Neuromodulation MEDTRONIC INTERSTIM THERAPY SYSTEM ............... March 14, 2011. emcdonald on DSK2BSOYB1PROD with NOTICES FDA–2011–M–0039 P070026 ................................ FDA–2011–M–0035 P100028 ................................ FDA–2011–M–0056 P090013 ................................ FDA–2011–M–0105 P080003 ................................ FDA2011–M–0131 P080027 (S1) ........................ FDA–2011–M–0132 H080005 ............................... FDA–2011–M–0170 P080025 ................................ FDA–2011–M–0175 VerDate Mar<15>2010 16:40 Jun 01, 2011 Jkt 223001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\02JNN1.SGM 02JNN1 31966 Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2011, THROUGH MARCH 31, 2011—Continued PMA No. Docket No. Applicant Trade name P80020 .................................. FDA–2011–M–0198 Seikagaku Corp ................... GEL–ONE .......................................................................... II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: May 27, 2011. Nancy K. Stade, Deputy Director for Policy Center for Devices and Radiological Health. [FR Doc. 2011–13692 Filed 6–1–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings emcdonald on DSK2BSOYB1PROD with NOTICES 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 meetings. The meetings 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: Center for Scientific Review Special Emphasis Panel, Member Conflict: Neurodegenerative Cardiovascular Disease and Imaging. Date: June 16, 2011. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Suzan Nadi, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301–435– 1259, nadis@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Neurodevelopment and Plasticity. VerDate Mar<15>2010 18:17 Jun 01, 2011 Jkt 223001 Date: June 27, 2011. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Laurent Taupenot, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4811, MSC 7850, Bethesda, MD 20892, 301–435– 1203, taupenol@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: AIDS/HIV Innovative Research Applications. Date: July 5, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Allerton Hotel, 701 North Michigan Avenue, Chicago, IL 60611. Contact Person: Kenneth A Roebuck, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, MSC 7852, Bethesda, MD 20892, (301) 435– 1166, roebuckk@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: Dermatology, Rheumatology and Inflammation. Date: July 5, 2011. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Aftab A Ansari, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892, 301–237– 9931, ansaria@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Gene Regulation and Genomics. Date: July 5, 2011. Time: 10 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Richard A Currie, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1108, MSC 7890, Bethesda, MD 20892, (301) 435– 1219, currieri@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Approval date March 22, 2011. Fellowships: Neurodevelopment, Synaptic Plasticity and Neurodegeneration. Date: July 6–7, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Avenue, NW., Washington, DC 20037. Contact Person: Mary Schueler, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5214, MSC 7846, Bethesda, MD 20892, 301–451– 0996, marygs@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Emphysema and Lung Development. Date: July 6–7, 2011. Time: 9 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: George M Barnas, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4220, MSC 7818, Bethesda, MD 20892, 301–435– 0696, barnasg@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: Cardiovascular Sciences. Date: July 7–8, 2011. Time: 7:30 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: InterContinental Chicago Hotel, 505 North Michigan Avenue, Chicago, IL 60611. Contact Person: Lawrence E Boerboom, PhD, Chief, CVRS IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4130, MSC 7814, Bethesda, MD 20892, (301) 435–8367, boerboom@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Fellowships: Behavioral Neuroscience. Date: July 7–8, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Avenue, NW., Washington, DC 20037. Contact Person: Kristin Kramer, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5205, MSC 7846, Bethesda, MD 20892, (301) 437– 0911, kramerkm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small E:\FR\FM\02JNN1.SGM 02JNN1

Agencies

[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Notices]
[Pages 31965-31966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13692]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0034, FDA-2011-M-0040, FDA-2011-M-0041, FDA-
2011-M-0039, FDA-2011-M-0035, FDA-2011-M-0056, FDA-2011-M-0105, FDA-
2011-M-0131, FDA-2011-M-0132, FDA-2011-M-0170, FDA-2011-M-0175, and
FDA-2011-M-0198]

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 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, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that amended 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 https://www.fda.gov.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C 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 FD&C 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 January 1, 2011, through March 31,
2011. 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, 2011,
Through March 31, 2011
----------------------------------------------------------------------------------------------------------------
PMA No. Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P010012 (S230)................... Boston Scientific BOSTON SCIENTIFIC September 16, 2010.
Corp. CARDIAC
RESYNCHRONIZATION
THERAPY DEFIBRILLATORS.
FDA-2011-M-0034
P100021.......................... Medtronic Vascular. MEDTRONIC VASCULAR December 16, 2010.
ENDURANT STENT GRAFT
SYSTEM.
FDA-2011-M-0040
P100010.......................... Medtronic Cryocath, ARCTIC FRONT December 17, 2010.
LP. CRYOCATHETER SYSTEM.
FDA-2011-M-0041
P070014 (S10).................... Bard Peripheral LIFESTENT AND LIFESTENT December 23, 2010.
Vascular. LX VASCULAR STENT
SYSTEMS.
FDA-2011-M-0039
P070026.......................... Depuy, Inc......... CERAMAX CERAMIC HIP December 23, 2010.
SYSTEM.
FDA-2011-M-0035
P100028.......................... Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011.
EXPANDABLE RENAL STENT
SYSTEM.
FDA-2011-M-0056
P090013.......................... Medtronic, Inc..... REVO MRI SURESCAN IPG February 8, 2011.
AND PACING SYSTEM.
FDA-2011-M-0105
P080003.......................... Hologic, Inc....... SELENIA DIMENSIONS 3D February 11, 2011.
SYSTEMS.
FDA2011-M-0131
P080027 (S1)..................... OraSure ORAQUICK HCV RAPID February 18, 2011.
Technologies, Inc. ANTIBODY TEST.
FDA-2011-M-0132
H080005.......................... Elana, Inc......... ELANA SURGICAL KIT HUD.. March 10, 2011.
FDA-2011-M-0170
P080025.......................... Medtronic MEDTRONIC INTERSTIM March 14, 2011.
Neuromodulation. THERAPY SYSTEM.
FDA-2011-M-0175

[[Page 31966]]

P80020........................... Seikagaku Corp..... GEL-ONE................. March 22, 2011.
FDA-2011-M-0198
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

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

Dated: May 27, 2011.
Nancy K. Stade,
Deputy Director for Policy Center for Devices and Radiological Health.
[FR Doc. 2011-13692 Filed 6-1-11; 8:45 am]
BILLING CODE 4160-01-P

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