[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)] [Notices] [Pages 44626-44628] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2017-20391] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA- 2016-M-1916, FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA- 2016-M-2183, FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA- 2016-M-2334, FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA- 2016-M-2499, FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA- 2016-M-2651, FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA- 2016-M-1972, FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA- 2016-M-3431, FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA- 2016-M-3915, FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA- 2016-M-4459, FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA- 2016-M-4653, FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA- 2017-M-0560, FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA- 2017-M-2652, FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA- 2017-M-1845, FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA- 2017-M-1950, FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA- 2017-M-2768, FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA- 2017-M-3579, FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA- 2017-M-3928, FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983] 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 Dockets Management Staff. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket Nos. FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-2016-M-1916, FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-2016-M-2183, FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-2016-M-2334, FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-2016-M-2499, FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-2016-M-2651, FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-2016-M-1972, FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-2016-M-3431, FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-2016-M-3915, FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-2016-M-4459, FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-2016-M-4653, FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-2017-M-0560, FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-2017-M-2652, FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-2017-M-1845, FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-2017-M-1950, FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-2017-M-2768, FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-2017-M-3579, FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-2017-M-3928, FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983 for ``Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the [[Page 44627]] docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 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 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 July 1, 2016, through June 30, 2017. 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 July 1, 2016 Through June 30, 2017 ---------------------------------------------------------------------------------------------------------------- Approval PMA No., Docket No. Applicant Trade name date ---------------------------------------------------------------------------------------------------------------- P130018, FDA-2015-M-4474............... Uromedica, Inc............ ProACTTM Adjustable Continence 11/24/15 Therapy for Men. P140003/S004, FDA-2016-M-1915.......... Abiomed, Inc.............. Impella Ventricular Support... 4/7/2016 P150034, FDA-2016-M-1837............... Revision Optics, Inc...... Raindrop Near Vision Inlay.... 6/29/2016 P150017, FDA-2016-M-1916............... Cartiva, Inc.............. Cartiva Synthetic Cartilage 7/1/2016 Implant. P150023, FDA-2016-M-1914............... Abbott Vascular........... Absorb GT1TM Bioresorbable 7/5/2016 Vascular Scaffold (BVS) System. P100020/S017, FDA-2016-M-1917.......... Roche Molecular Systems, cobas[supreg] HPV Test........ 7/7/2016 Inc. P090029/S003, FDA-2016-M-2182.......... Medtronic Sofamor Danek Prestige LPTM Cervical Disc... 7/7/2016 USA, Inc. P150038, FDA-2016-M-2183............... InSightec, Inc............ ExAblate Model 4000 Type 1.0 7/11/2016 System (ExAblate Neuro). P980040/S065, FDA-2016-M-2184.......... Abbott Medical Optics, Inc TECNIS[supreg] Symfony 7/15/2016 Extended Range of Vision Intraocular Lens. P150006, FDA-2016-M-2185............... Vasorum, Ltd.............. Celt ACD Vascular Closure 7/20/2016 Device. P160004, FDA-2016-M-2332............... W.L. Gore & Associates, Gore TIGRIS Vascular Stent.... 7/27/2016 Inc. P150003/S003, FDA-2016-M-2334.......... Boston Scientific Corp.... SYNERGYTM Everolimus-Eluting 7/29/2016 Platinum Chromium Coronary Stent System (Over-The-Wire & Monorail). P150037, FDA-2016-M-2333............... Alcon Laboratories, Inc... CyPass[supreg] System (Model 7/29/2016 241-S). P150001, FDA-2016-M-2500............... Medtronic MiniMed......... MiniMed 630G System with 8/10/2016 SmartGuard. P150036, FDA-2016-M-2485............... Edwards Lifesciences, LLC. Edwards INTUITY Elite Valve 8/12/2016 System. P130009/S057, FDA-2016-M-2498.......... Edwards Lifesciences LLC.. Edwards SAPIEN XT 8/18/2016 Transcatheter Heart Valve. P140031/S010, FDA-2016-M-2499.......... Edwards Lifesciences LLC.. Edwards SAPIEN 3 Transcatheter 8/18/2016 Heart Valve. P020045/S073, 2016-M-2649.............. Medtronic, Inc............ Freezor[supreg] Xtra Cardiac 8/31/2016 Cryoablation Catheter. P140010/S015, FDA-2016-M-2650.......... Medtronic Vascular, Inc... In PactTM AdmiralTM Paclitaxel- 9/7/2016 Coated Percutaneous Transluminal Angioplasty Balloon Catheter. P160001, FDA-2016-M-2651............... Obalon Therapeutics, Inc.. Obalon Balloon System......... 9/8/2016 P150040, FDA-2016-M-2735............... Carl Zeiss Meditec, Inc... VisuMax[supreg] Femtosecond 9/13/2016 Laser. P000025/S084, FDA-2016-M-2974.......... MED-EL Corp............... MED-EL Cochlear Implant System 9/15/2016 P150021, FDA-2016-M-2971............... Abbott Diabetes Care, Inc. Freestyle Libre Pro Flash 9/23/2016 Glucose Monitoring System. P080020/S020, FDA-2016-M-2975.......... Seikagaku Corp............ Gel-One[supreg]............... 9/27/2016 P160017, FDA-2016-M-1972............... Medtronic MiniMed, Inc.... MiniMed 670G System........... 9/28/2016 P150044, FDA-2016-M-2973............... Roche Molecular Systems, cobas[supreg] EGFR Mutation 9/28/2016 Inc. Test v2. P150030, FDA-2016-M-3430............... Smith & Nephew, Inc....... R3TM delta Ceramic Acetabular 10/17/2016 System. P160006, FDA-2016-M-3431............... Ventana Medical Systems, VENTANA PD-L1 (SP142) Assay... 10/18/2016 Inc. P150013/S001, FDA-2016-M-3913.......... Dako North America, Inc... PD-L1 IHC 22C3 pharmDX........ 10/24/2016 P120021, FDA-2016-M-3653............... St. Jude Medical, Inc..... AmplatzerTM PFO Occluder...... 10/28/2016 P150043, FDA-2016-M-3914............... QView Medical, Inc........ QVCAD System.................. 11/9/2016 P930016/S045, FDA-2016-M-3915.......... AMO Manufacturing USA, LLC Star S4 IR Excimer Laser 11/14/2016 System and iDesign Advanced WaveScan Studio. P020050/S023, FDA-2016-M-4046.......... Alcon Laboratories, Inc... WaveLight[supreg] EX500 and 11/21/2016 ALLEGRETTO WAVE[supreg] EYE-Q Excimer Laser Systems. P140029, FDA-2016-M-4344............... Q-Med AB.................. Restylane[supreg] Refyne and 12/9/2016 Restylane[supreg] Defyne. P130007/S016, FDA-2016-M-4458.......... Animas Corporation........ OneTouch VibeTM Plus System... 12/16/2016 P160018, FDA-2016-M-4459............... Foundation Medicine, Inc.. FoundationFocusTM CDxBRACA 12/19/2016 Assay. P120005/S041, FDA-2016-M-4483.......... Dexcom, Inc............... Dexcom G5 Mobile Continuous 12/20/2016 Glucose Monitoring System. P040020/S049, FDA-2016-M-4657.......... Alcon Laboratories, Inc... Acrysof[supreg] IQ 12/22/2016 ReSTOR[supreg] +3.0 D Multifocal Toric Intraocular Lens. P160019, FDA-2016-M-4530............... Roche Diagnostics......... Elecsys HBsAg II/Elecsys HBsAg 12/23/2016 Confirmatory Test/ PreciControl HBsAg II. P100022/S020, FDA-2016-M-4653.......... Cook Medical Inc.......... Zilver PTX Drug-Eluting 12/28/2016 Peripheral Stent. H070005, FDA-2017-M-0180............... AGA Medical Corp.......... AMPLATZERTM Post-Infarct 1/10/2017 Muscular VSD Occluder. P160031, FDA-2017-M-0181............... FUJIFILM Medical Systems ASPIRE Cristalle Digital 1/10/2017 U.S.A., Inc. Breast Tomosynthesis Option. P160008, FDA-2017-M-0229............... HeartSine Technologies LLC HeartSine samaritan[supreg] 1/12/2017 SAM 350P, SAM 360P, and SAM 450P Public Access Automated External Defibrillators, Accessories and Saver EVO[supreg] Software Version 1.4.0. P160021, FDA-2017-M-0560............... W.L. Gore & Associates, Gore[supreg] Viabahn[supreg] 1/27/2017 Inc. VBX Balloon Expandable Endoprosthesis. P130024/S009, FDA-2017-M-0831.......... Lutonix, Inc.............. Lutonix[supreg] 035 Drug 2/7/2017 Coated Balloon PTA Catheter. P140033, FDA-2017-M-0661............... St. Jude Medical, Inc..... MR Conditional Pacemaker 1/31/2017 System--Assurity MRITM and Endurity MRITM Pacemakers and Tendril MRITM 1200M LPA Lead. P160023, FDA-2017-M-0971............... Hologic, Inc.............. Aptima[supreg] HCV Quant Dx 2/13/2017 Assay. [[Page 44628]] P160003, FDA-2016-M-2652............... Biotronik, Inc............ PRO-Kinetic Energy Cobalt 2/14/2017 Chromium Coronary Stent System. P150039, FDA-2017-M-1121............... Tryton Medical, Inc....... TRYTON Side Branch Stent...... 2/21/2017 P160014, FDA-2017-M-1122............... CeloNova BioSciences, Inc. COBRA PzFTM NanoCoated 2/21/2017 Coronary Stent System. P100044/S023, FDA-2017-M-1228.......... Intersect ENT............. PROPEL[supreg] Contour Sinus 2/23/2017 Implant. P140017/S005, FDA-2017-M-1227.......... Medtronic, Inc............ MelodyTM Transcatheter 2/24/2017 Pulmonary Valve, EnsembleTM Transcatheter Valve Delivery System and EnsembleTM II Transcatheter Valve Delivery System. P160016, FDA-2017-M-1713............... Siemens Healthcare VERSANT[supreg] HCV GENOTYPE 3/14/2017 Diagnostics, Inc. 2.0 Assay (LiPA). P110033/S020, FDA-2017-M-1714.......... Allergan.................. Juv[eacute]derm VollureTM XC.. 3/17/2017 P160025, FDA-2017-M-1845............... Biotronik, Inc............ Astron Pulsar and Pulsar-18 3/23/2017 Stent Systems. P160009, FDA-2017-M-1950............... iCAD, Inc................. PowerLook[supreg] Tomo 3/24/2017 Detection Software. P160024, FDA-2017-M-2594............... Bard Peripheral Vascular, LifeStream Balloon Expandable 4/24/2017 Inc. Vascular Covered Stent. P160043, FDA-2017-M-2767............... Medtronic, Inc............ Resolute Onyx Zotarolimus- 4/28/2017 Eluting Coronary Stent System. P160040, FDA-2017-M-2766............... Invivoscribe Technologies, LeukoStrat[supreg] CDx FLT3 4/28/2017 Inc. Mutation Assay. P160046, FDA-2017-M-2768............... Ventana Medical Systems, VENTANA PD-L1 (SP263) Assay... 5/1/2017 Inc. H150003, FDA-2017-M-3103............... Wilson-Cook Medical, Inc.. FlourishTM Pediatric 5/12/2017 Esophageal Atresia Device. P160044, FDA-2017-M-3200............... Abbott Molecular, Inc..... Abbott RealTime CMV........... 5/18/2017 P160041, FDA-2017-M-3430............... Roche Molecular Systems, cobas[supreg] CMV............. 6/1/2017 Inc. P140031/S028, FDA-2017-M-3579.......... Edwards Lifesciences LLC.. Edwards SAPIEN 3TM 6/5/2017 Transcatheter Heart Valve and Accessories. P160035, FDA-2017-M-3580............... Berlin Heart, Inc......... EXCOR[supreg] Pediatric 6/6/2017 Ventricular Assist Device. P160047, FDA-2017-M-3778............... AEGEA Medical, Inc........ AEGEA Vapor SystemTM.......... 6/14/2017 H160002, FDA-2017-M-3839............... Pulsar Vascular, Inc...... PulseRider[supreg] Aneurysm 6/19/2017 Neck Reconstruction Device (``PulseRider''). P160045, FDA-2017-M-3928............... Life Technologies Corp.... OncomineTM Dx Target Test..... 6/22/2017 P150046, FDA-2017-M-3982............... SciBase AB................ Nevisense..................... 6/28/2017 P150048, FDA-2017-M-3990............... Edwards Lifesciences, LLC. Edwards Pericardial Aortic 6/29/2017 Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. P160038, FDA-2017-M-3983............... Illumina, Inc............. PraxisTM Extended RAS Panel... 6/29/2017 ---------------------------------------------------------------------------------------------------------------- II. Electronic Access Persons with access to the Internet may obtain the documents at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm. Dated: September 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20391 Filed 9-22-17; 8:45 am] BILLING CODE 4164-01-P