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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 Start Printed Page 57941effectiveness 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 (21 U.S.C. 360e(g)). 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, 2014, through June 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 April 1, 2014, Through June 30, 2014

PMA No., Docket No.ApplicantTrade nameApproval date
P130016, FDA-2014-M-0327Cochlear AmericasNucleus® HybridTM L24 Cochlear Implant SystemMarch 20, 2014.
P120020, FDA-2014-M-0434Abbott Vascular (IDEV Technologies, Inc.)SUPERA® Peripheral Stent SystemMarch 28, 2014.
P010015/S205, FDA-2014-M-0553Medtronic, IncCardiac Resynchronization Therapy Pacemaker (CRT-P) DevicesApril 10, 2014.
P010031/S381, FDA-2014-M-0553Medtronic, IncCardiac Resynchronization Therapy Defibrillator (CRT-D) DevicesApril 10, 2014.
P100020/S008, FDA-2014-M-0552Roche Molecular Systems, Inccobas® HPV TestApril 24, 2014.
P130008, FDA-2014-M-0690Inspire Medical Systems, IncInspire Upper Airway Stimulation (UAS) systemApril 30, 2014.
P110005, FDA-2014-M-0691IBSA Institut Biochimique SAGel-SynTM Sinovial (Sodium Hyaluronate 0.8%)May 9, 2014.
P110041, FDA-2014-M-0692Siemens Healthcare DiagnosticsADVIA Centaur® HBsAgII, ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control MaterialMay 16, 2014.
P110027, FDA-2014-M-0726QIAGEN Manchester Ltdtherascreen® KRAS RGQ PCR KitMay 23, 2014.
P100045, FDA-2014-M-0727CardioMEMS, IncCardioMEMSTM HF SystemMay 28, 2014.
P130027, FDA-2014-M-0866QIAGEN, Incartus® CMV RGQ MDx KitJune 2, 2014.
P040024/S072, FDA-2014-M-0872Valeant Pharmaceuticals North America LLC/MedicisRestylane Silk Injectable GelJune 13, 2014.

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: September 23, 2014

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-22987 Filed 9-25-14; 8:45 am]