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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 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, 2014, through September 30, 2014. 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, 2014, Through September 30, 2014

PMA No., Docket No.ApplicantTrade nameApproval date
P130021/S002, FDA-2014-M-0867Medtronic CoreValve LLCMedtronic CoreValveTM System (MCS)June 12, 2014.
P130009, FDA-2014-M-0874Edwards Lifesciences, LLCEdwards SAPIEN XTTM Transcatheter Heart Valve and AccessoriesJune 16, 2014.
P130029, FDA-2014-M-0875Bard Peripheral Vascular, IncFluency® Plus Endovascular Stent GraftJune 17, 2014.
P130011, FDA-2014-M-1064Sorin Group Canada, IncFreedom SOLO Stentless Heart Valve and SOLO Smart Heart ValveJune 24, 2014.
P130030, FDA-2014-M-1060Boston Scientific CorpREBELTM Platinum Chromium Coronary Stent System (MonorailTM and Over-The-Wire)June 27, 2014.
P090029, FDA-2014-M-1113Medtronic Sofamor Danek USA, IncPrestige® LP Cervical DiscJuly 24, 2014.
H130005, FDA-2014-M-1114MicroVention, IncLow-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.)July 25, 2014.
P130017, FDA-2014-M-1193Exact Sciences, IncCOLOGUARDTMAugust 11, 2014.
H120003, FDA-2014-M-1265XVIVO Perfusion, IncXVIVO Perfusion System (XPSTM) with STEEN SolutionTM PerfusateAugust 12, 2014.
H130004, FDA-2014-M-1280Plexision, IncPleximmuneTMAugust 26, 2014.
P130020, FDA-2014-M-1279GE HealthcareSenoClaireAugust 26, 2014.
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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: February 5, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-02783 Filed 2-10-15; 8:45 am]