| Page Range | 60393-60394 | |
| FR Document | 2015-25352 |
[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)] [Notices] [Pages 60393-60394] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25352] ----------------------------------------------------------------------- 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 Sec. 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 [[Page 60394]] 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[supreg] 2.5 System... 3/23/2015 P130014, FDA-2015-M-1065.............. HyperBranch Medical Adherus[supreg] AutoSpray 3/30/2015 Technology, Inc. Dural Sealant. P130021/S010, FDA-2015-M-1064......... Medtronic CoreValve, LLC. Medtronic CoreValve[supreg] 3/30/2015 System. P110015, FDA-2015-M-1178.............. Advanced Breath Gastric Emptying Breath Test 4/6/2015 Diagnostics, LLC. (GEBT). P040020/S050, FDA-2015-M-1325......... Alcon Research, Ltd...... AcrySof IQ ReSTOR +2.5 D 4/13/2015 Multifocal Intraocular Lens. P120023, FDA-2015-M-1326.............. AcuFocusTM, Inc.......... KAMRATM inlay................ 4/17/2015 H130007, FDA-2014-M-2247.............. CVRx[supreg], Inc........ Barostim neoTM Legacy System. 12/12/2014 P140011, FDA-2015-M-1460.............. Siemens Medical Solutions MAMMOMAT Inspiration with 4/21/2015 USA, Inc. Tomosynthesis Option. P120017, FDA-2015-M-1461.............. Medtronic, Inc........... Model 5071 Lead.............. 4/27/2015 P130012, FDA-2015-M-1557.............. Greatbatch Medical....... Myopore Sutureless Myocardial 4/30/2015 Pacing Lead. P140023, FDA-2015-M-1708.............. Roche Molecular Systems, cobas[supreg] KRAS Mutation 5/7/2015 Inc. Test. P130022, FDA-2015-M-1709.............. Nevro Corp............... Nevro Senza Spinal Cord 5/8/2015 Stimulation (SCS) System. P140026, FDA-2015-M-1956.............. Silk Road Medical, Inc... ENROUTETM Transcarotid Stent 5/18/2015 System. P140004, FDA-2015-M-1957.............. Vertiflex[supreg], Inc... Superion[supreg] InterSpinous 5/20/2015 Spacer. P140002, FDA-2015-M-1958.............. Terumo Medical Corp...... Misago[supreg] Peripheral 5/22/2015 Self-expanding Stent System. P120005/S031, FDA-2015-M-1959......... Dexcom, Inc.............. Dexcom G4[supreg]PLATINUM 5/22/2015 (Pediatric) Continuous Glucose Monitoring System. P110010/S096, FDA-2015-M-2077......... Boston Scientific Corp... PROMUS[supreg] ElementTM Plus 6/1/2015 and Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM and Over- the-Wire). P050052/S049, FDA-2015-M-2078......... Merz North America....... Radiesse[supreg] Injectable 6/4/2015 Implant. ---------------------------------------------------------------------------------------------------------------- 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] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 80 FR 60393 |