Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 47210-47211 [2011-19734]

Download as PDF 47210 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices Dated: July 28, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–19622 Filed 8–3–11; 8:45 am] BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0518] Notices of Filing of Petitions for Food Additives and Color Additives; Relocation in the Federal Register AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is notifying the public that notices of filing of petitions for food additives and color additives that are published in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) will now be published in the ‘‘Proposed Rules’’ section of the Federal Register. Notices of filing have historically been published in the ‘‘Notices’’ section of the Federal Register. The Office of the Federal Register (OFR) recently informed FDA that, under OFR rules, these documents actually fall into the ‘‘Proposed Rules’’ category and requested that FDA reclassify these notices of filing documents as proposed rules. This change is effective immediately. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Regulations Editorial Section, Office of Policy, Planning and Budget, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 32, Rm. 3208, Silver Spring, MD 20993–0002, 301–796–9148, joyce.strong@fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: sroberts on DSK5SPTVN1PROD with NOTICES I. Background Section 409 of the FD&C Act (21 U.S.C. 348) establishes the food additive petition approval process for food additives for use in human and animal food. Section 409(b)(5) requires that the Secretary of Health and Human Services publish notice in general terms of the receipt of a petition within 30 days of its filing. Similarly, section 721 of the FD&C Act (21 U.S.C. 379e) establishes a petition approval process for color additives used in food, drugs, cosmetics, and devices, and requires that the Secretary publish notice in general terms of the receipt of a color additive petition within 30 days of its filing. These responsibilities of the Secretary VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 have been delegated to the Commissioner of Food and Drugs and redelegated to certain other FDA officials. These notices of filing are published in the Federal Register. Under the Federal Register Act (44 U.S.C. chapter 15), the Administrative Committee of the Federal Register issues regulations regarding publishing documents in the Federal Register (1 CFR chapter I). Based on these governing regulations, the OFR classifies Agency documents published in the Federal Register in one of three categories: rules and regulations, proposed rules, and notices. The regulation establishing document types is 1 CFR 5.9. FDA’s section 409 and section 721 notices of filing have historically been published in the ‘‘Notices’’ section of the Federal Register. OFR recently informed FDA that, in their view, these documents actually fall into the ‘‘Proposed Rules’’ category and requested that FDA classify future such notices of filing documents as proposed rules (Ref. 1). Accordingly, FDA documents providing notice under section 409(b)(5) or section 721(d)(1) of the FD&C Act will appear in the proposed rule section of the Federal Register. This change is effective immediately. II. Reference The following reference has been placed on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Memo from Amy P. Bunk, Office of the Federal Register, to Joyce Strong, Food and Drug Administration, May 9, 2011. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–M–0323, FDA– 2011–M–0256, FDA–2011–M–0257, FDA– 2011–M–0241, FDA–2011–M–0284, FDA– 2011–M–0295, FDA–2011–M–0300, FDA– 2011–M–0296, FDA–2011–M–0342, FDA– 2011–M–0338, FDA–2011–M–0343, FDA– 2011–M–0348, FDA–2011–M–0349, FDA– 2011–M–0430, FDA–2011–M–0431, FDA– 2011–M–0445, FDA–2011–M–0470, FDA– 2011–M–0472, FDA–2011–M–0502, and FDA–2011–M–0503] 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 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. SUMMARY: 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: [FR Doc. 2011–19765 Filed 8–3–11; 8:45 am] Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301–796–6570. SUPPLEMENTARY INFORMATION: BILLING CODE 4160–01–P I. Background Dated: July 29, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. PO 00000 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 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 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1 47211 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices 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 April 1, 2011, through June 30, 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 APRIL 1, 2011, THROUGH JUNE 30, 2011 PMA No./Docket No. Applicant Trade name Approval date P050050 FDA–2011–M–0323 ....... P060004(S1) FDA–2011–M–0256 P100040 FDA–2011–M–0257 ....... H100002 FDA–2011–M–0241 ....... P100018 FDA–2011–M–0284 ....... Small Bone Innovations, Inc ......... Carl Zeiss Meditec, Inc ................. Medtronic Vascular ....................... NeuroVasx, Inc ............................. Chestnut Medical Technologies, Inc. NovoCure, Ltd ............................... Roche Molecular Systems, Inc ..... St. Jude Medical, Inc .................... Boston Scientific Corp .................. Scandinavian total ankle replacement system ......... Meditec MEL 80 excimer laser system .................... Valiant thoracic stent graft system ........................... cPAX aneurysm treatment system ........................... Pipeline embolization device .................................... May 27, 2009. March 28, 2011. April 1, 2011. April 1, 2011. April 6, 2011. April April April April Alcon Research, Ltd ..................... NovoCure Ltd.’s NovoTTF–100A treatment kit ........ cobas HPV test ......................................................... Trifecta heart valve ................................................... ION paclitaxel-eluting coronary stent system (monorail and over-the-wire systems). AcrySof toric IOL and AcrySof IQ toric IOL .............. P100034 P100020 P100029 P100023 FDA–2011–M–0295 FDA–2011–M–0300 FDA–2011–M–0296 FDA–2011–M–0342 ....... ....... ....... ....... 8, 2011. 19, 2011. 20, 2011. 22, 2011. P930014 (S45) FDA–2011–M– 0338. P040012 (S34) FDA–2011–M– 0343. P090028 FDA–2011–M–0348 ....... Abbott Vascular, Inc ...................... RX Acculink carotid stent system ............................. May 6, 2011. Ortho-Clinical Diagnostics, Inc ...... May 11, 2011. P100017 FDA–2011–M–0349 ....... Abbott Molecular, Inc .................... P100013 FDA–2011–M–0430 ....... P070015 (S54) FDA–2011–M– 0431. Cordis Corp ................................... Abbott Vascular ............................. P100014 P090002 P100027 P100031 ....... ....... ....... ....... Oceana Therapeutics, Inc ............. Depuy Orthopaedics, Inc .............. Ventana Medical Systems, Inc ..... Roche Diagnostics Corp ............... P100032 FDA–2011–M–0503 ....... Roche Diagnostics Corp ............... Vitros immunodiagnostic products HBeAg reagent pack/products HBeAg calibrator/products HBe controls. Abbott RealTime HCV, Abbott RealTime HCV amplification reagent kit, Abbott RealTime HCV control kit, Abbott RealTime HCV calibrator kit, and optional UNG Uracil-N-glycosylase. Cordis ExoSeal vascular closure device .................. Xience nano everolimus-eluting coronary stent system and Promus everolimus-eluting coronary stent system. Solesta injectable gel ................................................ Pinnacle complete acetabular hip system ................ INFORM HER2 dual ISH DNA probe cocktail .......... Elecsys anti-HBc immunoassay and Elecsys PreciControl anti-HBc for use on the modular Analytics E170 immunoassay analyzer. Elecsys anti-HBc immunoassay and Elecsys PreciControl anti-HBc for use on the Elecsys 2010 immunoassay analyzer. FDA–2011–M–0445 FDA–2011–M–0470 FDA–2011–M–0472 FDA–2011–M–0502 II. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Food and Drug Administration sroberts on DSK5SPTVN1PROD with NOTICES Dated: July 29, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [Docket No. FDA–2011–N–0332] [FR Doc. 2011–19734 Filed 8–3–11; 8:45 am] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability BILLING CODE 4160–01–P AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and SUMMARY: VerDate Mar<15>2010 17:29 Aug 03, 2011 Jkt 223001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 May 3, 2011. May 17, 2011. May 19, 2011. May 24, 2011. May 27, 2011. June 13, 2011. June 14, 2011. June 22, 2011. June 27, 2011. Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency’s report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6466, Silver Spring, MD 20993–0002, 301– 796–0700; or Stephen Ripley, Center for FOR FURTHER INFORMATION CONTACT: E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47210-47211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19734]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0323, FDA-2011-M-0256, FDA-2011-M-0257, FDA-
2011-M-0241, FDA-2011-M-0284, FDA-2011-M-0295, FDA-2011-M-0300, FDA-
2011-M-0296, FDA-2011-M-0342, FDA-2011-M-0338, FDA-2011-M-0343, FDA-
2011-M-0348, FDA-2011-M-0349, FDA-2011-M-0430, FDA-2011-M-0431, FDA-
2011-M-0445, FDA-2011-M-0470, FDA-2011-M-0472, FDA-2011-M-0502, and
FDA-2011-M-0503]

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, 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 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

[[Page 47211]]

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 April 1, 2011, through June 30, 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 April 1, 2011, Through
June 30, 2011
----------------------------------------------------------------------------------------------------------------
PMA No./Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P050050 FDA-2011-M-0323....... Small Bone Scandinavian total ankle May 27, 2009.
Innovations, Inc. replacement system.
P060004(S1) FDA-2011-M-0256... Carl Zeiss Meditec, Meditec MEL 80 excimer laser March 28, 2011.
Inc. system.
P100040 FDA-2011-M-0257....... Medtronic Vascular.... Valiant thoracic stent graft April 1, 2011.
system.
H100002 FDA-2011-M-0241....... NeuroVasx, Inc........ cPAX aneurysm treatment system.. April 1, 2011.
P100018 FDA-2011-M-0284....... Chestnut Medical Pipeline embolization device.... April 6, 2011.
Technologies, Inc.
P100034 FDA-2011-M-0295....... NovoCure, Ltd......... NovoCure Ltd.'s NovoTTF-100A April 8, 2011.
treatment kit.
P100020 FDA-2011-M-0300....... Roche Molecular cobas HPV test.................. April 19, 2011.
Systems, Inc.
P100029 FDA-2011-M-0296....... St. Jude Medical, Inc. Trifecta heart valve............ April 20, 2011.
P100023 FDA-2011-M-0342....... Boston Scientific Corp ION paclitaxel-eluting coronary April 22, 2011.
stent system (monorail and over-
the-wire systems).
P930014 (S45) FDA-2011-M-0338. Alcon Research, Ltd... AcrySof toric IOL and AcrySof IQ May 3, 2011.
toric IOL.
P040012 (S34) FDA-2011-M-0343. Abbott Vascular, Inc.. RX Acculink carotid stent system May 6, 2011.
P090028 FDA-2011-M-0348....... Ortho-Clinical Vitros immunodiagnostic products May 11, 2011.
Diagnostics, Inc. HBeAg reagent pack/products
HBeAg calibrator/products HBe
controls.
P100017 FDA-2011-M-0349....... Abbott Molecular, Inc. Abbott RealTime HCV, Abbott May 17, 2011.
RealTime HCV amplification
reagent kit, Abbott RealTime
HCV control kit, Abbott
RealTime HCV calibrator kit,
and optional UNG Uracil-N-
glycosylase.
P100013 FDA-2011-M-0430....... Cordis Corp........... Cordis ExoSeal vascular closure May 19, 2011.
device.
P070015 (S54) FDA-2011-M-0431. Abbott Vascular....... Xience nano everolimus-eluting May 24, 2011.
coronary stent system and
Promus everolimus-eluting
coronary stent system.
P100014 FDA-2011-M-0445....... Oceana Therapeutics, Solesta injectable gel.......... May 27, 2011.
Inc.
P090002 FDA-2011-M-0470....... Depuy Orthopaedics, Pinnacle complete acetabular hip June 13, 2011.
Inc. system.
P100027 FDA-2011-M-0472....... Ventana Medical INFORM HER2 dual ISH DNA probe June 14, 2011.
Systems, Inc. cocktail.
P100031 FDA-2011-M-0502....... Roche Diagnostics Corp Elecsys anti-HBc immunoassay and June 22, 2011.
Elecsys PreciControl anti-HBc
for use on the modular
Analytics E170 immunoassay
analyzer.
P100032 FDA-2011-M-0503....... Roche Diagnostics Corp Elecsys anti-HBc immunoassay and June 27, 2011.
Elecsys PreciControl anti-HBc
for use on the Elecsys 2010
immunoassay analyzer.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

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

Dated: July 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological
Health.
[FR Doc. 2011-19734 Filed 8-3-11; 8:45 am]
BILLING CODE 4160-01-P

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