2015-02783. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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 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.	Applicant	Trade name	Approval date
P130021/S002, FDA-2014-M-0867	Medtronic CoreValve LLC	Medtronic CoreValveTM System (MCS)	June 12, 2014.
P130009, FDA-2014-M-0874	Edwards Lifesciences, LLC	Edwards SAPIEN XTTM Transcatheter Heart Valve and Accessories	June 16, 2014.
P130029, FDA-2014-M-0875	Bard Peripheral Vascular, Inc	Fluency® Plus Endovascular Stent Graft	June 17, 2014.
P130011, FDA-2014-M-1064	Sorin Group Canada, Inc	Freedom SOLO Stentless Heart Valve and SOLO Smart Heart Valve	June 24, 2014.
P130030, FDA-2014-M-1060	Boston Scientific Corp	REBELTM Platinum Chromium Coronary Stent System (MonorailTM and Over-The-Wire)	June 27, 2014.
P090029, FDA-2014-M-1113	Medtronic Sofamor Danek USA, Inc	Prestige® LP Cervical Disc	July 24, 2014.
H130005, FDA-2014-M-1114	MicroVention, Inc	Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.)	July 25, 2014.
P130017, FDA-2014-M-1193	Exact Sciences, Inc	COLOGUARDTM	August 11, 2014.
H120003, FDA-2014-M-1265	XVIVO Perfusion, Inc	XVIVO Perfusion System (XPSTM) with STEEN SolutionTM Perfusate	August 12, 2014.
H130004, FDA-2014-M-1280	Plexision, Inc	PleximmuneTM	August 26, 2014.
P130020, FDA-2014-M-1279	GE Healthcare	SenoClaire	August 26, 2014.

II. Electronic Access

Persons with access to the Internet may obtain the documents at http://www.fda.gov/​MedicalDevices/​ProductsandMedicalProcedures/​DeviceApprovalsandClearances/​PMAApprovals/​default.htm.

Dated: February 5, 2015.

Leslie Kux,

Associate Commissioner for Policy.