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

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Food and Drug Administration, HHS.




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.

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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.

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I. Background

In accordance with sections 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 July 1, 2012, through September 30, 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 July 1, 2012, Through September 30, 2012

PMA No., Docket No.ApplicantTrade nameApproval date
P980022/S010, FDA-2012-M-0965Medtronic MiniMed, IncGuardian Telemetered Glucose Monitoring System (TGMS)January 7, 2004.
P000008/S017, FDA-2012-M-1013Allergan, IncLAP-BAND TM Adjustable Gastric Banding SystemFebruary 16, 2011.
P100049, FDA-2012-M-0893Torax Medical, IncLINX TM Reflux Management SystemMarch 22, 2012.
P010031/S232, FDA-2012-M-0814Medtronic, IncConcerto/Concerto II; Consulta; Maximo II; and Protecta/Protecta XT Families of CRT-DsApril 4, 2012.
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P080030, FDA-2012-M-0712Glaukos CorpGlaukos iStent® Trabecular Micro-Bypass Stent and InserterJune 25, 2012.
P110007, FDA-2012-M-0734Abbott Medical Optics, IncHealon® EndoCoat OpViscosurgical Ophthalmic Device (OVD) (3% Sodium Hyaluronate)July 2, 2012.
P110037, FDA-2012-M-0713Roche Molecular Systems, IncCOBAS® AmpliPrep/COBAS® TaqMan® CMV TestJuly 5, 2012.
P110030, FDA-2012-M-0735QIAGEN Manchester, Ltdtherascreen® KRAS RGQ PCR KitJuly 6, 2012.
P110043, FDA-2012-M-0833Abbott VascularOmnilink Elite Vascular Balloon-Expandable Stent SystemJuly 31, 2012.
P040024/S056, FDA-2012-M-0968Medicis Aesthetics Holdings, IncRestylane L Injectable GelAugust 30, 2012.
P110006, FDA-2012-M-1011U-Systems, Incsomo-v® Automated Breast Ultrasound System (ABUS)September 18, 2012

II. Electronic Access

Persons with access to the Internet may obtain the documents at​MedicalDevices/​ProductsandMedicalProcedures/​DeviceApprovalsandClearances/​PMAApprovals/​default.htm.

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Dated: December 31, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-00004 Filed 1-4-13; 8:45 am]