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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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.
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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.||Applicant||Trade name||Date of action|
|P070023, FDA-2013-M-1324||Fzio Med, Inc||Oxiplex®/SP Gel||Denied October 21, 2013.|
|P110016/S008, FDA-2013-M-1693||St. Jude Medical, Inc||Therapy Cool Flex Ablation Catheter||Approved December 18, 2013.|
|P130004, FDA-2014-M-0069||Ocular Therapeutics, Inc||ReSure® Sealant||Approved January 8, 2014.|
|P130021, FDA-2014-M-0166||Medtronic CoreValve LLC||Medtronic CoreValveTM System||Approved January 17, 2014.|
|P100040/S012, FDA-2014-M-0167||Medtronic Vascular||Valiant Thoracic Stent Graft with Captivia Delivery System||Approved January 22, 2014.|
|P120005/S002, FDA-2014-M-0224||Dexcom, Inc||Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System||Approved February 3, 2014.|
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|P090031, FDA-2014-M-0254||Anika Therapeutics, Inc||MONOVISCTM Injectable Intra-articular Device||Approved February 25, 2014.|
|P130015, FDA-2013-M-0326||Roche Diagnostics Operations, Inc||Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg||Approved March 14, 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.
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Dated: September 19, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-22807 Filed 9-24-14; 8:45 am]
BILLING CODE 4164-01-P