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 Start Printed Page 14053


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 October 1, 2013, through December 31, 2013. 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 October 1, 2013, Through December 31, 2013

PMA No., Docket No.ApplicantTrade NameApproval Date
P040043/S051, FDA-2013-M-1323W.L. Gore & Associates, IncGORE® TAG® Thoracic EndoprosthesisSeptember 10, 2013.
P970053/S011, FDA-2013-M-1362Nidek Co., LtdNidek EC-5000 Excimer Laser SystemSeptember 30, 2013.
P020050/S012, FDA-2013-M-1321Alcon Research, LtdALLEGRETTO WAVE® Eye-Q Excimer Laser SystemOctober 2, 2013.
H120005, FDA-2013-M-1322Kaneka Pharma America LLCKaneka Liposorber® LA-15 SystemOctober 10, 2013.
P130005, FDA-2013-M-1363Cardiovascular Systems, IncDiamondback 360® Coronary Orbital Arthrectomy SystemOctober 21, 2013.
P110033, FDA-2013-M-1364AllerganJUVÉDERM® VOLUMATM XCOctober 22, 2013.
P100009, FDA-2013-M-1365Abbott VascularMitraClip Clip Delivery System (MitraClip CDS)October 24, 2013.
P100026, FDA-2013-M-1488NeuroPace, IncRNS® SystemNovember 14, 2013.
P130006, FDA-2013-M-1605W.L. Gore & Associates, IncGORE® VIABAHN® Endoprosthesis & GORE® VIABAHB® Endoprosthesis with Heparin BioActive SurfaceDecember 5, 2013.

II. Electronic Access

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

Start Signature

Dated: March 7, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2014-05429 Filed 3-11-14; 8:45 am]