Skip to Content


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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


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.

Start Further Info


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.

End Further Info End Preamble Start Supplemental 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 January 1, 2014, through March 31, 2014, and includes one denial action 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, 2014, Through March 31, 2014

PMA No., Docket No.ApplicantTrade nameDate of action
P070023, FDA-2013-M-1324Fzio Med, IncOxiplex®/SP GelDenied October 21, 2013.
P110016/S008, FDA-2013-M-1693St. Jude Medical, IncTherapy Cool Flex Ablation CatheterApproved December 18, 2013.
P130004, FDA-2014-M-0069Ocular Therapeutics, IncReSure® SealantApproved January 8, 2014.
P130021, FDA-2014-M-0166Medtronic CoreValve LLCMedtronic CoreValveTM SystemApproved January 17, 2014.
P100040/S012, FDA-2014-M-0167Medtronic VascularValiant Thoracic Stent Graft with Captivia Delivery SystemApproved January 22, 2014.
P120005/S002, FDA-2014-M-0224Dexcom, IncDexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring SystemApproved February 3, 2014.
Start Printed Page 57561
P090031, FDA-2014-M-0254Anika Therapeutics, IncMONOVISCTM Injectable Intra-articular DeviceApproved February 25, 2014.
P130015, FDA-2013-M-0326Roche Diagnostics Operations, IncElecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAgApproved March 14, 2014.

II. Electronic Access

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

Start Signature

Dated: September 19, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2014-22807 Filed 9-24-14; 8:45 am]