Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 15779-15780 [2012-6390]

Download as PDF 15779 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Reference Number and date Title of standard 1 Recognition No. M. Tissue Engineering 15–32 ........................... 15–33 ........................... 15–34 ........................... 15–35 ........................... 15–36 ........................... 1 All Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1 H NMR) Spectroscopy. Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC–MALS). Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC–MALS). Standard Guide for Characterization of Hydrogels used in Regenerative Medicine .................. Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs). ASTM F2605–08 1. ASTM F2900–11. ASTM F2383–11. standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA’s Internet site at https:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. mstockstill on DSK4VPTVN1PROD with NOTICES ASTM F2260–03 (Reapproved 2008). ASTM F2602–08 1. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard; (2) any reference number and date; (3) name and address of the national or international standards development organization; (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply; and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. CDRH maintains a site on the Internet for easy access to information VerDate Mar<15>2010 17:10 Mar 15, 2012 Jkt 226001 including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards-related documents. After publication in the Federal Register, this notice announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 028’’ will be available on the CDRH home page. You may access the CDRH home page at https://www.fda.gov/ MedicalDevices. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ Standards. This Federal Register document on modifications in FDA’s recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 028. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Dated: March 12, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–6389 Filed 3–15–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2011–M–0735, FDA– 2011–M–0736, FDA–2011–M–0737, FDA– 2011–M–0746, FDA–2011–M–0786, FDA– 2011–M–0791, FDA–2011–M–0792, FDA– 2011–M–0796, FDA–2011–M–0832, FDA– 2011–M–0837, FDA–2011–M–0848, FDA– 2011–M–0865, FDA–2011–M–0866, FDA– 2011–M–0910, and FDA–2011–M–0917] 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: E:\FR\FM\16MRN1.SGM 16MRN1 15780 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 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 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 October 1, 2011, through December 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 OCTOBER 1, 2011, THROUGH DECEMBER 31, 2011 PMA No., Docket No. Applicant Trade name Approval date P110003, FDA–2011–M–0746 ............. P090024, FDA–2011–M–0737 ............. Pluromed, Inc ...................................... Siemens Healthcare Diagnostics ........ September 28, 2011. October 11, 2011. P040024 (S51), FDA–2011–M–0735 ... P010029 (S8), FDA–2011–M–0736 ..... P110022, FDA–2011–M–0786 ............. Medicis Aesthetics, Inc ........................ Ferring Pharmaceuticals, Inc .............. Roche Diagnostics Corp ..................... P110011, FDA–2011–M–0791 ............. Medtronic Ireland ................................. P100042, FDA–2011–M–0792 ............. P110019, FDA–2011–M–0796 ............. Gen-Probe Incorporated ...................... Abbott Vascular ................................... P100041, FDA–2011–M–0837 ............. Edwards Lifesciences, LLC ................. P090016, FDA–2011–M–0832 ............. H090002, FDA–2011–M–0848 ............. P110010, FDA–2011–M–0865 ............. Merz Aesthetics, Inc ............................ BSD Medical Corp ............................... Boston Scientific Corp ......................... P100024, FDA–2011–M–0866 ............. P110025, FDA–2011–M–0917 ............. Dako Denmark A/S ............................. Roche Diagnostics Corp ..................... P100046, FDA–2011–M–0910 ............. AtriCure Inc ......................................... LEGOO ................................................ ADVIA CENTAUR HBEAG assay and quality control material. RESTYLANE injectable gel ................. EUFLEXXA (1% sodium hyaluronate) ELECSYS anti-HBC IGM immunoassay and ELECSYS PRECICONTROL anti-HBC IGM. ASSURANT COBALT iliac balloon-expandable stent system. APTIMA HPV assay ............................ XIENCE PRIME and XIENCE PRIME LL EVEROLIMUS-eluting coronary stent system. EDWARDS SAPIEN transcatheter heart valve and RETROFLEX 3 delivery system, RETROFLEX balloon catheter and crimper. BELOTERO balance ........................... BSD–2000 hyperthermia system ........ PROMUS ELEMENT PLUS EVEROLIMUS-eluting platinum chromium coronary stent system. HER2 CISH PHARMDX kit ................. ELECSYS anti-HBC IGM immunoassay and ELECSYS PRECICONTROL anti-HBC IGM for use on the MODULAR ANALYTICS E170 immunoassay analyze. ATRICURE SYNERGY ablation system. mstockstill on DSK4VPTVN1PROD with NOTICES II. Electronic Access Persons with access to the Internet may obtain the documents at: https://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm; and https://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ HDEApprovals/ucm161827.htm. VerDate Mar<15>2010 17:10 Mar 15, 2012 Jkt 226001 Dated: March 12, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–6390 Filed 3–15–12; 8:45 am] October 11, 2011. October 11, 2011. October 26, 2011. October 26, 2011. October 28, 2011. November 1, 2011. November 2, 2011. November 14, 2011. November 18, 2011. November 22, 2011. November 30, 2011. December 14, 2011. December 14, 2011. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health New Proposed Collection; Comment Request: Child Health Disparities Measurement for the National Children’s Study BILLING CODE 4160–01–P In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15779-15780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6390]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0735, FDA-2011-M-0736, FDA-2011-M-0737, FDA-
2011-M-0746, FDA-2011-M-0786, FDA-2011-M-0791, FDA-2011-M-0792, FDA-
2011-M-0796, FDA-2011-M-0832, FDA-2011-M-0837, FDA-2011-M-0848, FDA-
2011-M-0865, FDA-2011-M-0866, FDA-2011-M-0910, and FDA-2011-M-0917]

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.

[[Page 15780]]

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 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 October 1, 2011, through December 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 October 1, 2011,
Through December 31, 2011
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P110003, FDA-2011-M-0746.......... Pluromed, Inc........ LEGOO............... September 28, 2011.
P090024, FDA-2011-M-0737.......... Siemens Healthcare ADVIA CENTAUR HBEAG October 11, 2011.
Diagnostics. assay and quality
control material.
P040024 (S51), FDA-2011-M-0735.... Medicis Aesthetics, RESTYLANE injectable October 11, 2011.
Inc. gel.
P010029 (S8), FDA-2011-M-0736..... Ferring EUFLEXXA (1% sodium October 11, 2011.
Pharmaceuticals, Inc. hyaluronate).
P110022, FDA-2011-M-0786.......... Roche Diagnostics ELECSYS anti-HBC IGM October 26, 2011.
Corp. immunoassay and
ELECSYS
PRECICONTROL anti-
HBC IGM.
P110011, FDA-2011-M-0791.......... Medtronic Ireland.... ASSURANT COBALT October 26, 2011.
iliac balloon-
expandable stent
system.
P100042, FDA-2011-M-0792.......... Gen-Probe APTIMA HPV assay.... October 28, 2011.
Incorporated.
P110019, FDA-2011-M-0796.......... Abbott Vascular...... XIENCE PRIME and November 1, 2011.
XIENCE PRIME LL
EVEROLIMUS-eluting
coronary stent
system.
P100041, FDA-2011-M-0837.......... Edwards Lifesciences, EDWARDS SAPIEN November 2, 2011.
LLC. transcatheter heart
valve and RETROFLEX
3 delivery system,
RETROFLEX balloon
catheter and
crimper.
P090016, FDA-2011-M-0832.......... Merz Aesthetics, Inc. BELOTERO balance.... November 14, 2011.
H090002, FDA-2011-M-0848.......... BSD Medical Corp..... BSD-2000 November 18, 2011.
hyperthermia system.
P110010, FDA-2011-M-0865.......... Boston Scientific PROMUS ELEMENT PLUS November 22, 2011.
Corp. EVEROLIMUS-eluting
platinum chromium
coronary stent
system.
P100024, FDA-2011-M-0866.......... Dako Denmark A/S..... HER2 CISH PHARMDX November 30, 2011.
kit.
P110025, FDA-2011-M-0917.......... Roche Diagnostics ELECSYS anti-HBC IGM December 14, 2011.
Corp. immunoassay and
ELECSYS
PRECICONTROL anti-
HBC IGM for use on
the MODULAR
ANALYTICS E170
immunoassay analyze.
P100046, FDA-2011-M-0910.......... AtriCure Inc......... ATRICURE SYNERGY December 14, 2011.
ablation system.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

Persons with access to the Internet may obtain the documents at:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm; and
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm.

Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6390 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P

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