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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 Dockets Management Staff.


You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 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
  • 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 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 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:​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 and insert the Start Printed Page 44627docket 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.

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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.

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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 § 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

PMA No., Docket No.ApplicantTrade nameApproval date
P130018, FDA-2015-M-4474Uromedica, IncProACTTM Adjustable Continence Therapy for Men11/24/15
P140003/S004, FDA-2016-M-1915Abiomed, IncImpella Ventricular Support4/7/2016
P150034, FDA-2016-M-1837Revision Optics, IncRaindrop Near Vision Inlay6/29/2016
P150017, FDA-2016-M-1916Cartiva, IncCartiva Synthetic Cartilage Implant7/1/2016
P150023, FDA-2016-M-1914Abbott VascularAbsorb GT1TM Bioresorbable Vascular Scaffold (BVS) System7/5/2016
P100020/S017, FDA-2016-M-1917Roche Molecular Systems, Inccobas® HPV Test7/7/2016
P090029/S003, FDA-2016-M-2182Medtronic Sofamor Danek USA, IncPrestige LPTM Cervical Disc7/7/2016
P150038, FDA-2016-M-2183InSightec, IncExAblate Model 4000 Type 1.0 System (ExAblate Neuro)7/11/2016
P980040/S065, FDA-2016-M-2184Abbott Medical Optics, IncTECNIS® Symfony Extended Range of Vision Intraocular Lens7/15/2016
P150006, FDA-2016-M-2185Vasorum, LtdCelt ACD Vascular Closure Device7/20/2016
P160004, FDA-2016-M-2332W.L. Gore & Associates, IncGore TIGRIS Vascular Stent7/27/2016
P150003/S003, FDA-2016-M-2334Boston Scientific CorpSYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-Wire & Monorail)7/29/2016
P150037, FDA-2016-M-2333Alcon Laboratories, IncCyPass® System (Model 241-S)7/29/2016
P150001, FDA-2016-M-2500Medtronic MiniMedMiniMed 630G System with SmartGuard8/10/2016
P150036, FDA-2016-M-2485Edwards Lifesciences, LLCEdwards INTUITY Elite Valve System8/12/2016
P130009/S057, FDA-2016-M-2498Edwards Lifesciences LLCEdwards SAPIEN XT Transcatheter Heart Valve8/18/2016
P140031/S010, FDA-2016-M-2499Edwards Lifesciences LLCEdwards SAPIEN 3 Transcatheter Heart Valve8/18/2016
P020045/S073, 2016-M-2649Medtronic, IncFreezor® Xtra Cardiac Cryoablation Catheter8/31/2016
P140010/S015, FDA-2016-M-2650Medtronic Vascular, IncIn PactTM AdmiralTM Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter9/7/2016
P160001, FDA-2016-M-2651Obalon Therapeutics, IncObalon Balloon System9/8/2016
P150040, FDA-2016-M-2735Carl Zeiss Meditec, IncVisuMax® Femtosecond Laser9/13/2016
P000025/S084, FDA-2016-M-2974MED-EL CorpMED-EL Cochlear Implant System9/15/2016
P150021, FDA-2016-M-2971Abbott Diabetes Care, IncFreestyle Libre Pro Flash Glucose Monitoring System9/23/2016
P080020/S020, FDA-2016-M-2975Seikagaku CorpGel-One®9/27/2016
P160017, FDA-2016-M-1972Medtronic MiniMed, IncMiniMed 670G System9/28/2016
P150044, FDA-2016-M-2973Roche Molecular Systems, Inccobas® EGFR Mutation Test v29/28/2016
P150030, FDA-2016-M-3430Smith & Nephew, IncR3TM delta Ceramic Acetabular System10/17/2016
P160006, FDA-2016-M-3431Ventana Medical Systems, IncVENTANA PD-L1 (SP142) Assay10/18/2016
P150013/S001, FDA-2016-M-3913Dako North America, IncPD-L1 IHC 22C3 pharmDX10/24/2016
P120021, FDA-2016-M-3653St. Jude Medical, IncAmplatzerTM PFO Occluder10/28/2016
P150043, FDA-2016-M-3914QView Medical, IncQVCAD System11/9/2016
P930016/S045, FDA-2016-M-3915AMO Manufacturing USA, LLCStar S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio11/14/2016
P020050/S023, FDA-2016-M-4046Alcon Laboratories, IncWaveLight® EX500 and ALLEGRETTO WAVE® EYE-Q Excimer Laser Systems11/21/2016
P140029, FDA-2016-M-4344Q-Med ABRestylane® Refyne and Restylane® Defyne12/9/2016
P130007/S016, FDA-2016-M-4458Animas CorporationOneTouch VibeTM Plus System12/16/2016
P160018, FDA-2016-M-4459Foundation Medicine, IncFoundationFocusTM CDxBRACA Assay12/19/2016
P120005/S041, FDA-2016-M-4483Dexcom, IncDexcom G5 Mobile Continuous Glucose Monitoring System12/20/2016
P040020/S049, FDA-2016-M-4657Alcon Laboratories, IncAcrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens12/22/2016
P160019, FDA-2016-M-4530Roche DiagnosticsElecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg II12/23/2016
P100022/S020, FDA-2016-M-4653Cook Medical IncZilver PTX Drug-Eluting Peripheral Stent12/28/2016
H070005, FDA-2017-M-0180AGA Medical CorpAMPLATZERTM Post-Infarct Muscular VSD Occluder1/10/2017
P160031, FDA-2017-M-0181FUJIFILM Medical Systems U.S.A., IncASPIRE Cristalle Digital Breast Tomosynthesis Option1/10/2017
P160008, FDA-2017-M-0229HeartSine Technologies LLCHeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public Access Automated External Defibrillators, Accessories and Saver EVO® Software Version 1.4.01/12/2017
P160021, FDA-2017-M-0560W.L. Gore & Associates, IncGore® Viabahn® VBX Balloon Expandable Endoprosthesis1/27/2017
P130024/S009, FDA-2017-M-0831Lutonix, IncLutonix® 035 Drug Coated Balloon PTA Catheter2/7/2017
P140033, FDA-2017-M-0661St. Jude Medical, IncMR Conditional Pacemaker System—Assurity MRITM and Endurity MRITM Pacemakers and Tendril MRITM 1200M LPA Lead1/31/2017
P160023, FDA-2017-M-0971Hologic, IncAptima® HCV Quant Dx Assay2/13/2017
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P160003, FDA-2016-M-2652Biotronik, IncPRO-Kinetic Energy Cobalt Chromium Coronary Stent System2/14/2017
P150039, FDA-2017-M-1121Tryton Medical, IncTRYTON Side Branch Stent2/21/2017
P160014, FDA-2017-M-1122CeloNova BioSciences, IncCOBRA PzFTM NanoCoated Coronary Stent System2/21/2017
P100044/S023, FDA-2017-M-1228Intersect ENTPROPEL® Contour Sinus Implant2/23/2017
P140017/S005, FDA-2017-M-1227Medtronic, IncMelodyTM Transcatheter Pulmonary Valve, EnsembleTM Transcatheter Valve Delivery System and EnsembleTM II Transcatheter Valve Delivery System2/24/2017
P160016, FDA-2017-M-1713Siemens Healthcare Diagnostics, IncVERSANT® HCV GENOTYPE 2.0 Assay (LiPA)3/14/2017
P110033/S020, FDA-2017-M-1714AllerganJuvéderm VollureTM XC3/17/2017
P160025, FDA-2017-M-1845Biotronik, IncAstron Pulsar and Pulsar-18 Stent Systems3/23/2017
P160009, FDA-2017-M-1950iCAD, IncPowerLook® Tomo Detection Software3/24/2017
P160024, FDA-2017-M-2594Bard Peripheral Vascular, IncLifeStream Balloon Expandable Vascular Covered Stent4/24/2017
P160043, FDA-2017-M-2767Medtronic, IncResolute Onyx Zotarolimus- Eluting Coronary Stent System4/28/2017
P160040, FDA-2017-M-2766Invivoscribe Technologies, IncLeukoStrat® CDx FLT3 Mutation Assay4/28/2017
P160046, FDA-2017-M-2768Ventana Medical Systems, IncVENTANA PD-L1 (SP263) Assay5/1/2017
H150003, FDA-2017-M-3103Wilson-Cook Medical, IncFlourishTM Pediatric Esophageal Atresia Device5/12/2017
P160044, FDA-2017-M-3200Abbott Molecular, IncAbbott RealTime CMV5/18/2017
P160041, FDA-2017-M-3430Roche Molecular Systems, Inccobas® CMV6/1/2017
P140031/S028, FDA-2017-M-3579Edwards Lifesciences LLCEdwards SAPIEN 3TM Transcatheter Heart Valve and Accessories6/5/2017
P160035, FDA-2017-M-3580Berlin Heart, IncEXCOR® Pediatric Ventricular Assist Device6/6/2017
P160047, FDA-2017-M-3778AEGEA Medical, IncAEGEA Vapor SystemTM6/14/2017
H160002, FDA-2017-M-3839Pulsar Vascular, IncPulseRider® Aneurysm Neck Reconstruction Device (“PulseRider”)6/19/2017
P160045, FDA-2017-M-3928Life Technologies CorpOncomineTM Dx Target Test6/22/2017
P150046, FDA-2017-M-3982SciBase ABNevisense6/28/2017
P150048, FDA-2017-M-3990Edwards Lifesciences, LLCEdwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve6/29/2017
P160038, FDA-2017-M-3983Illumina, IncPraxisTM Extended RAS Panel6/29/2017

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 12, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

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[FR Doc. 2017-20391 Filed 9-22-17; 8:45 am]