Document ID: FDA-2011-M-0919-0001
Agency: fda
Document Type: Notice
Title: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability: Medical Devices
Posted Date: 2012-06-14T04:00Z

[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.

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