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Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

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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.


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.


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.


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

PMA No., Docket No.ApplicantTrade nameApproval date
P090012, FDA-2012-M-0074Mela Sciences, IncMelaFindNovember 1, 2011.
H100008, FDA-2011-M-0726TriVascular, IncOVATION Abdominal Stent Graft SystemNovember 1, 2011.
H090002, FDA-2011-M-0848BSD Medical CorporationBSD-2000 Hyperthermia SystemNovember 18, 2011.
H100004, FDA-2011-M-0919Berlin Heart, IncBerlin Heart EXCOR Pediatric Ventricular Assist DeviceDecember 16, 2011.
P110031, FDA-2012-M-0024Roche Diagnostics CorpElecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgMJanuary 3, 2012.
P040043.S040, FDA-2012-M-0056W.L. Gore & Associates, IncGore TAG Thoracic EndoprosthesisJanuary 13, 2012.
P100039, FDA-2012-M-0075Siemens Healthcare Diagnostics IncADVIA Centaur Anti-HBs2 Assay and Quality Control MaterialJanuary 20, 2012.
P100005, FDA-2012-M-0082Vucomp, IncM-Vu Algorithm EngineJanuary 23, 2012.
P110016, FDA-2012-M-0112St. Jude Medical, Inc. (parent company for Irvine Biomedical, Inc.)Therapy Cool Path Duo/Safire BLU Duo Ablation Catheter and IBI 1500T9-CP V1.6 Cardiac Ablation GeneratorJanuary 25, 2012.
P080012, FDA-2012-M-0180Flowonix Medical, Inc. (approved under Medasys, Inc.)Prometra Programmable Infusion Pump SystemFebruary 7, 2012.
P100007, FDA-2012-M-0172Almen Laboratories, IncBreast Companion Software SystemFebruary 10, 2012.
P100033, FDA-2012-M-0173Gen-Probe IncPROGENSA PCA3 AssayFebruary 13, 2012.
P110013, FDA-2012-M-0177Medtronic VascularResolute MicroTrac/Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemFebruary 17, 2012.
P110028, FDA-2012-M-0181Abbott Vascular IncAbsolute Pro Vascular Self-Expanding Stent SystemFebruary 22, 2012.
P100025, FDA-2012-M-0207Otsuka America Pharmaceutical, IncBreathTek UBT H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (PUHR-CA), Version 1.0February 22, 2012.
P100023.S015, FDA-2012-M-0208Boston Scientific CorpION Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems)February 22, 2012.
P060008.S046, FDA-2012-M-0210Boston Scientific CorpTAXUS Liberté Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems)February 22, 2012.
P030025.S086, FDA-2012-M-0209Boston Scientific CorpTAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems)February 22, 2012.
P110023, FDA-2012-M-0221ev3, IncEverflex Self-Expanding Peripheral Stent System (Everflex)March 7, 2012.
P070004, FDA-2012-M-0250Sientra, IncSIENTRA Silicone Gel Breast ImplantsMarch 9, 2012.

II. Electronic Access

Persons with access to the Internet may obtain the documents at and

Dated: June 8, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

[FR Doc. 2012-14486 Filed 6-13-12; 8:45 am]