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.
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.
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.||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 Stent Graft System||November 1, 2011.|
|H090002, FDA-2011-M-0848||BSD Medical Corporation||BSD-2000 Hyperthermia System||November 18, 2011.|
|H100004, FDA-2011-M-0919||Berlin Heart, Inc||Berlin Heart EXCOR Pediatric Ventricular Assist Device||December 16, 2011.|
|P110031, FDA-2012-M-0024||Roche Diagnostics Corp||Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM||January 3, 2012.|
|P040043.S040, FDA-2012-M-0056||W.L. Gore & Associates, Inc||Gore TAG Thoracic Endoprosthesis||January 13, 2012.|
|P100039, FDA-2012-M-0075||Siemens Healthcare Diagnostics Inc||ADVIA Centaur Anti-HBs2 Assay and Quality Control Material||January 20, 2012.|
|P100005, FDA-2012-M-0082||Vucomp, Inc||M-Vu Algorithm Engine||January 23, 2012.|
|P110016, FDA-2012-M-0112||St. 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 Generator||January 25, 2012.|
|P080012, FDA-2012-M-0180||Flowonix Medical, Inc. (approved under Medasys, Inc.)||Prometra Programmable Infusion Pump System||February 7, 2012.|
|P100007, FDA-2012-M-0172||Almen Laboratories, Inc||Breast Companion Software System||February 10, 2012.|
|P100033, FDA-2012-M-0173||Gen-Probe Inc||PROGENSA PCA3 Assay||February 13, 2012.|
|P110013, FDA-2012-M-0177||Medtronic Vascular||Resolute MicroTrac/Resolute Integrity Zotarolimus-Eluting Coronary Stent System||February 17, 2012.|
|P110028, FDA-2012-M-0181||Abbott Vascular Inc||Absolute Pro Vascular Self-Expanding Stent System||February 22, 2012.|
|P100025, FDA-2012-M-0207||Otsuka America Pharmaceutical, Inc||BreathTek UBT H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (PUHR-CA), Version 1.0||February 22, 2012.|
|P100023.S015, FDA-2012-M-0208||Boston Scientific Corp||ION Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems)||February 22, 2012.|
|P060008.S046, FDA-2012-M-0210||Boston Scientific Corp||TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems)||February 22, 2012.|
|P030025.S086, FDA-2012-M-0209||Boston Scientific Corp||TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems)||February 22, 2012.|
|P110023, FDA-2012-M-0221||ev3, Inc||Everflex Self-Expanding Peripheral Stent System (Everflex)||March 7, 2012.|
|P070004, FDA-2012-M-0250||Sientra, Inc||SIENTRA Silicone Gel Breast Implants||March 9, 2012.|
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm and http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm.
Dated: June 8, 2012.
Assistant Commissioner for Policy.
[FR Doc. 2012-14486 Filed 6-13-12; 8:45 am]
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