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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. Start Printed Page 50423360e(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 April 1, 2013, through June 30, 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 April 1, 2013, Through June 30, 2013

PMA No., Docket No.ApplicantTrade nameApproval date
P120016, FDA-2013-M-0592Cardiva Medical, Inc.VASCADE Vascular Closure System (VCS)January 31, 2013.
P070026/S004, FDA-2013-M-0462DePuy Orthopaedics, Inc.DuPuy Ceramax Ceramic Total Hip SystemApril 2, 2013.
P960043/S080, FDA-2013-M-0464Abbott VascularPERCLOSE PROGLIDE Suture Mediated Closure SystemApril 15, 2013.
P980040/S039, FDA-2013-M-0463Abbott Medical Optics, Inc.TECNIS Toric 1-Piece Intraocular Lens (IOL) and the TECNIS Toric Calculator SystemApril 15, 2013.
P080009, FDA-2013-M-0549Ethicon Endo-Surgery, Inc.SEDASYS Computer-Assisted Personalized Sedation SystemMay 3, 2013.
P120019, FDA-2013-M-0594Roche Molecular Systems, Inc.COBAS EGFR Mutation TestMay 14, 2013.
P080003/S001, FDA-2013-M-0595Hologic, Inc.Selenia Dimensions 3D SystemMay 16, 2013.
P030002/S027, FDA-2013-M-0724Bausch+Lomb, Inc.TRULIGN Toric Posterior Chamber Intraocular LensMay 20, 2013.
P120014, FDA-2013-M-0709bioMérieux, Inc.THxID BRAF Kit for use on the ABI 7500 Fast DX Real-Time PCR InstrumentMay 29, 2013.
P060028, FDA-2013-M-0738Mentor Worldwide LLCMEMORYSHAPE Breast ImplantsJune 14, 2013.
P120012, FDA-2013-M-0758Abbott Molecular, Inc.Abbott RealTi m e HCV Genotype II, Abbott RealTi m e HCV Genotype II Control Kit, and Uracil-N-Glycosylase (UNG)June 20, 2013.

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: August 13, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-20085 Filed 8-16-13; 8:45 am]