Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 35690-35691 [2012-14486]

Download as PDF 35690 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency’s Division of Dockets Management. Food and Drug Administration 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: [Docket Nos. FDA–2011–M–0726, FDA– 2011–M–0919, FDA–2012–M–0024, FDA– 2012–M–0056, FDA–2012–M–0074, FDA– 2012–M–0075, FDA–2012–M–0082, FDA– 2012–M–0112, FDA–2012–M–0172, FDA– 2012–M–0173, FDA–2012–M–0177, FDA– 2012–M–0180, FDA–2012–M–0181, FDA– 2012–M–0207, FDA–2012–M–0208, FDA– 2012–M–0209, FDA–2012–M–0210, FDA– 2012–M–0221, and FDA–2012–M–0250] 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 SUMMARY: 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 January 1, 2012, through March 31, 2012. 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, 2012, THROUGH MARCH 31, 2012 Applicant Trade name P090012, FDA–2012–M–0074 ............ H100008, FDA–2011–M–0726 ............ Mela Sciences, Inc .............................. TriVascular, Inc ................................... H090002, FDA–2011–M–0848 ............ H100004, FDA–2011–M–0919 ............ BSD Medical Corporation .................... Berlin Heart, Inc .................................. P110031, FDA–2012–M–0024 ............ Roche Diagnostics Corp ..................... P040043.S040, FDA–2012–M–0056 ... P100039, FDA–2012–M–0075 ............ W.L. Gore & Associates, Inc ............... Siemens Healthcare Diagnostics Inc .. P100005, FDA–2012–M–0082 ............ P110016, FDA–2012–M–0112 ............ Vucomp, Inc ........................................ St. Jude Medical, Inc. (parent company for Irvine Biomedical, Inc.). P080012, FDA–2012–M–0180 ............ P100007, FDA–2012–M–0172 ............ P100033, FDA–2012–M–0173 ............ P110013, FDA–2012–M–0177 ............ pmangrum on DSK3VPTVN1PROD with NOTICES PMA No., Docket No. Flowonix Medical, Inc. (approved under Medasys, Inc.). Almen Laboratories, Inc ...................... Gen-Probe Inc ..................................... Medtronic Vascular .............................. P110028, FDA–2012–M–0181 ............ Abbott Vascular Inc ............................. P100025, FDA–2012–M–0207 ............ Otsuka America Pharmaceutical, Inc .. P100023.S015, FDA–2012–M–0208 ... Boston Scientific Corp ......................... MelaFind .............................................. OVATION Abdominal Stent Graft System. BSD–2000 Hyperthermia System ....... Berlin Heart EXCOR Pediatric Ventricular Assist Device. Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM. Gore TAG Thoracic Endoprosthesis ... ADVIA Centaur Anti-HBs2 Assay and Quality Control Material. M–Vu Algorithm Engine ...................... Therapy Cool Path Duo/Safire BLU Duo Ablation Catheter and IBI 1500T9–CP V1.6 Cardiac Ablation Generator. Prometra Programmable Infusion Pump System. Breast Companion Software System .. PROGENSA PCA3 Assay ................... Resolute MicroTrac/Resolute Integrity Zotarolimus-Eluting Coronary Stent System. Absolute Pro Vascular Self-Expanding Stent System. BreathTek UBT H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (PUHR–CA), Version 1.0. ION Paclitaxel-Eluting Coronary Stent System (Monorail and Over-TheWire Delivery Systems). VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 Approval date November 1, 2011. November 1, 2011. November 18, 2011. December 16, 2011. January 3, 2012. January 13, 2012. January 20, 2012. January 23, 2012. January 25, 2012. February 7, 2012. February 10, 2012. February 13, 2012. February 17, 2012. February 22, 2012. February 22, 2012. February 22, 2012. 35691 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2012, THROUGH MARCH 31, 2012—Continued PMA No., Docket No. Applicant Trade name P060008.S046, FDA–2012–M–0210 ... Boston Scientific Corp ......................... P030025.S086, FDA–2012–M–0209 ... Boston Scientific Corp ......................... P110023, FDA–2012–M–0221 ............ ev3, Inc ................................................ P070004, FDA–2012–M–0250 ............ Sientra, Inc .......................................... ´ TAXUS Liberte Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). Everflex Self-Expanding Peripheral Stent System (Everflex). SIENTRA Silicone Gel Breast Implants. 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: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14486 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Update to Electronic Common Technical Document Module 1 AGENCY: Food and Drug Administration, HHS. pmangrum on DSK3VPTVN1PROD with NOTICES ACTION: Notice of meeting. The Food and Drug Administration (FDA) is announcing the following meeting: Update to Electronic Common Technical Document Module 1. The topic to be discussed is final documentation of the Electronic Common Technical Document (eCTD) Module 1, which is used for electronic submission of administrative and prescribing information by industry. The purpose of the meeting is to provide clarification and answer questions from industry and software vendors regarding the changes being made to this module. Registration is required in advance and participation will be limited. DATES: Date and Time: The meeting will be held on Tuesday, September 18, 2012, from 8 a.m. to 11:30 a.m. VerDate Mar<15>2010 14:34 Jun 13, 2012 The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Great Room 1503, Silver Spring, MD 20993. The following link contains public meeting attendee information as well as frequently asked questions and answers regarding public meetings at White Oak: https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. CONTACT: Julie Quinonez, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1135, Silver Spring, MD 20993, 301–796– 0282, FAX: 301–796–9876, email: Julie.Quinonez@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) to Julie Quinonez (see Contact). Registrations will be accepted in the order that they are received with a limit of 350. SUPPLEMENTARY INFORMATION: The eCTD is an International Conference on Harmonization (ICH) standard based on specifications developed by ICH and its member parties. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have been receiving submissions in the eCTD format since 2003, and the eCTD has been the standard for electronic submissions to CDER and CBER since January 1, 2008. In fact, the majority of new electronic submissions are now received in eCTD format. Since adoption of the eCTD standard, it has become necessary to update the administrative portion of the eCTD Module 1 to reflect regulatory changes; to provide clarification of business rules for submission, processing, and review; to refine the characterization of promotional labeling and advertising material; and to facilitate automated processing of LOCATION: Jkt 226001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Approval date February 22, 2012. February 22, 2012. March 7, 2012. March 9, 2012. submissions. In the process of considering these changes, FDA has previously made available for comment versions of documents that support making regulatory submissions in electronic format using the (eCTD) specifications. These draft documents represented FDA’s major updates to Module 1 of the eCTD based on previous comments. FDA will make available revised versions of these documents in preparation for this meeting. These documents will be posted at: https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ ElectronicSubmissions/ucm253101.htm. If you need special accommodations due to a disability, please contact Julie Quinonez (see Contact) at least 7 days in advance. Dated: June 8, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14469 Filed 6–13–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0517] Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be SUMMARY: E:\FR\FM\14JNN1.SGM 14JNN1

Agencies

[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35690-35691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14486]

[[Page 35690]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0726, FDA-2011-M-0919, FDA-2012-M-0024, FDA-
2012-M-0056, FDA-2012-M-0074, FDA-2012-M-0075, FDA-2012-M-0082, FDA-
2012-M-0112, FDA-2012-M-0172, FDA-2012-M-0173, FDA-2012-M-0177, FDA-
2012-M-0180, FDA-2012-M-0181, FDA-2012-M-0207, FDA-2012-M-0208, FDA-
2012-M-0209, FDA-2012-M-0210, FDA-2012-M-0221, and FDA-2012-M-0250]

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 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, 2012, through March 31,
2012. 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, 2012,
Through March 31, 2012
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P090012, FDA-2012-M-0074.......... Mela Sciences, Inc... MelaFind............ November 1, 2011.
H100008, FDA-2011-M-0726.......... TriVascular, Inc..... OVATION Abdominal November 1, 2011.
Stent Graft System.
H090002, FDA-2011-M-0848.......... BSD Medical BSD-2000 November 18, 2011.
Corporation. Hyperthermia System.
H100004, FDA-2011-M-0919.......... Berlin Heart, Inc.... Berlin Heart EXCOR December 16, 2011.
Pediatric
Ventricular Assist
Device.
P110031, FDA-2012-M-0024.......... Roche Diagnostics Elecsys Anti-HBc IgM January 3, 2012.
Corp. Immunoassay and
Elecsys
PreciControl Anti-
HBc IgM.
P040043.S040, FDA-2012-M-0056..... W.L. Gore & Gore TAG Thoracic January 13, 2012.
Associates, Inc. Endoprosthesis.
P100039, FDA-2012-M-0075.......... Siemens Healthcare ADVIA Centaur Anti- January 20, 2012.
Diagnostics Inc. HBs2 Assay and
Quality Control
Material.
P100005, FDA-2012-M-0082.......... Vucomp, Inc.......... M-Vu Algorithm January 23, 2012.
Engine.
P110016, FDA-2012-M-0112.......... St. Jude Medical, Therapy Cool Path January 25, 2012.
Inc. (parent company Duo/Safire BLU Duo
for Irvine Ablation Catheter
Biomedical, Inc.). and IBI 1500T9-CP
V1.6 Cardiac
Ablation Generator.
P080012, FDA-2012-M-0180.......... Flowonix Medical, Prometra February 7, 2012.
Inc. (approved under Programmable
Medasys, Inc.). Infusion Pump
System.
P100007, FDA-2012-M-0172.......... Almen Laboratories, Breast Companion February 10, 2012.
Inc. Software System.
P100033, FDA-2012-M-0173.......... Gen-Probe Inc........ PROGENSA PCA3 Assay. February 13, 2012.
P110013, FDA-2012-M-0177.......... Medtronic Vascular... Resolute MicroTrac/ February 17, 2012.
Resolute Integrity
Zotarolimus-Eluting
Coronary Stent
System.
P110028, FDA-2012-M-0181.......... Abbott Vascular Inc.. Absolute Pro February 22, 2012.
Vascular Self-
Expanding Stent
System.
P100025, FDA-2012-M-0207.......... Otsuka America BreathTek UBT H. February 22, 2012.
Pharmaceutical, Inc. pylori Kit and
Pediatric Urea
Hydrolysis Rate
Calculation
Application (PUHR-
CA), Version 1.0.
P100023.S015, FDA-2012-M-0208..... Boston Scientific ION Paclitaxel- February 22, 2012.
Corp. Eluting Coronary
Stent System
(Monorail and Over-
The-Wire Delivery
Systems).

[[Page 35691]]

P060008.S046, FDA-2012-M-0210..... Boston Scientific TAXUS Libert[eacute] February 22, 2012.
Corp. Paclitaxel-Eluting
Coronary Stent
System (Monorail
and Over-The-Wire
Delivery Systems).
P030025.S086, FDA-2012-M-0209..... Boston Scientific TAXUS Express2 February 22, 2012.
Corp. Paclitaxel-Eluting
Coronary Stent
System (Monorail
and Over-The-Wire
Delivery Systems).
P110023, FDA-2012-M-0221.......... ev3, Inc............. Everflex Self- March 7, 2012.
Expanding
Peripheral Stent
System (Everflex).
P070004, FDA-2012-M-0250.......... Sientra, Inc......... SIENTRA Silicone Gel March 9, 2012.
Breast Implants.
----------------------------------------------------------------------------------------------------------------

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: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14486 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P

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