Notices. Notice
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/register/2015/10/06/2015-25352A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-M-1064, FDA-2015-M-1065, FDA-2015-M-1177, FDA-2015-M-1178, FDA-2015-M-1325, FDA-2015-M-1326, FDA-2015-M-1460, FDA-2015-M-1461, FDA-2015-M-1557, FDA-2015-M-1708, FDA-2015-M-1709, FDA-2015-M-1956, FDA-2015-M-1957, FDA-2015-M-1958, FDA-2015-M-1959, FDA-2015-M-2077, FDA-2015-M-2078, FDA-2014-M-2247] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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. ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576. SUPPLEMENTARY 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 April 1, 2015, through June 30, 2015. 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, 2015 Through June 30, 2015 PMA No., Docket No. Applicant Trade name Approval date P140003, FDA-2015-M-1177 ABIOMED, Inc Impella® 2.5 System 3/23/2015 P130014, FDA-2015-M-1065 HyperBranch Medical Technology, Inc Adherus® AutoSpray Dural Sealant 3/30/2015 P130021/S010, FDA-2015-M-1064 Medtronic CoreValve, LLC Medtronic CoreValve® System 3/30/2015 P110015, FDA-2015-M-1178 Advanced Breath Diagnostics, LLC Gastric Emptying Breath Test
(GEBT)4/6/2015 P040020/S050, FDA-2015-M-1325 Alcon Research, Ltd AcrySof IQ ReSTOR +2.5 D Multifocal Intraocular Lens 4/13/2015 P120023, FDA-2015-M-1326 AcuFocus TM , Inc KAMRA TM inlay 4/17/2015 H130007, FDA-2014-M-2247 CVRx®, Inc Barostim neo TM Legacy System 12/12/2014 P140011, FDA-2015-M-1460 Siemens Medical Solutions USA, Inc MAMMOMAT Inspiration with Tomosynthesis Option 4/21/2015 P120017, FDA-2015-M-1461 Medtronic, Inc Model 5071 Lead 4/27/2015 P130012, FDA-2015-M-1557 Greatbatch Medical Myopore Sutureless Myocardial Pacing Lead 4/30/2015 P140023, FDA-2015-M-1708 Roche Molecular Systems, Inc cobas® KRAS Mutation Test 5/7/2015 P130022, FDA-2015-M-1709 Nevro Corp Nevro Senza Spinal Cord Stimulation
(SCS)System 5/8/2015 P140026, FDA-2015-M-1956 Silk Road Medical, Inc ENROUTE TM Transcarotid Stent System 5/18/2015 P140004, FDA-2015-M-1957 Vertiflex®, Inc Superion® InterSpinous Spacer 5/20/2015 P140002, FDA-2015-M-1958 Terumo Medical Corp Misago® Peripheral Self-expanding Stent System 5/22/2015 P120005/S031, FDA-2015-M-1959 Dexcom, Inc Dexcom G4®PLATINUM (Pediatric) Continuous Glucose Monitoring System 5/22/2015 P110010/S096, FDA-2015-M-2077 Boston Scientific Corp PROMUS® Element TM Plus and Promus PREMIER TM Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail TM and Over-the-Wire) 6/1/2015 P050052/S049, FDA-2015-M-2078 Merz North America Radiesse® Injectable Implant 6/4/2015 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.* Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25352 Filed 10-5-15; 8:45 am]
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