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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 October 1, 2012, through December 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.Start Printed Page 17416

Table 1—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2012, Through December 31, 2012

PMA No., Docket No.ApplicantTrade nameApproval date
P110038, FDA-2012-M-1012Bolton Medical IncRelay® Thoracic Stent-Graft with Plus Delivery SystemSeptember 21, 2012.
P110042, FDA-2012-M-1048Cameron Health, IncSubcutaneous Implantable Defibrillator (S-ICD®) SystemSeptember 28, 2012.
P100003, FDA-2012-M-1039Globus Medical, IncSecure-C Artificial Cervical DiscSeptember 28, 2012.
P120005, FDA-2012-M-1049Dexcom, IncDexcom G4 PLATINUM Continuous Glucose Monitoring SystemOctober 5, 2012.
P120006, FDA-2012-M-1110TriVascular, IncOvation Abdominal Stent Graft SystemOctober 5, 2012.
P120007, FDA-2012-M-1066Gen-Probe, IncAPTIMA® HPV 16 18/45 Genotype AssayOctober 12, 2012.
P110008, FDA-2012-M-1085Paradigm Spine, LLCcoflex® Interlaminar TechnologyOctober 17, 2012.
P110039, FDA-2012-M-1084InSightec, IncInSightec ExAblate® SystemOctober 18, 2012.
P110021, FDA-2012-M-1088Edwards Lifesciences, LLCEdwards SAPIENTM Transcatheter Heart ValveOctober 19, 2012.
P100040/S008, FDA-2012-M-1109Medtronic VascularValiant® Thoracic Stent Graft with the Captivia Delivery SystemOctober 26, 2012.
P100012, FDA-2012-M-1111NuVasive, IncPCM® Cervical Disc SystemOctober 26, 2012.
P120002, FDA-2012-M-1183Cordis CorporationS.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems.November 7, 2012
P100022, FDA-2012-M-1146Cook, IncZilver PTX Drug-Eluting Peripheral StentNovember 14, 2012.
P100047, FDA-2012-M-1184HeartWare, IncHeartWare® Ventricular Assist SystemNovember 20, 2012.
P120008, FDA-2012-M-1176Abbott LaboratoriesARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP ControlsNovember 28, 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: March 15, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-06429 Filed 3-20-13; 8:45 am]