82 FR 184 pgs. 44626-44628 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 82Number: 184Pages: 44626 - 44628
Pages: 44626, 44627, 44628Docket number: [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]
FR document: [FR Doc. 2017-20391 Filed 9-22-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
[top] 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
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 §?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.
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| PMA No., Docket No. | Applicant | Trade name | Approval date |
|---|---|---|---|
| P130018, FDA-2015-M-4474 | Uromedica, Inc | ProACT TM Adjustable Continence Therapy for Men | 11/24/15 |
| 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 Implant | 7/1/2016 |
| P150023, FDA-2016-M-1914 | Abbott Vascular | Absorb GT1 TM Bioresorbable Vascular Scaffold (BVS) System | 7/5/2016 |
| P100020/S017, FDA-2016-M-1917 | Roche Molecular Systems, Inc | cobas® HPV Test | 7/7/2016 |
| P090029/S003, FDA-2016-M-2182 | Medtronic Sofamor Danek USA, Inc | Prestige LP TM Cervical Disc | 7/7/2016 |
| P150038, FDA-2016-M-2183 | InSightec, Inc | ExAblate Model 4000 Type 1.0 System (ExAblate Neuro) | 7/11/2016 |
| P980040/S065, FDA-2016-M-2184 | Abbott Medical Optics, Inc | TECNIS® Symfony Extended Range of Vision Intraocular Lens | 7/15/2016 |
| P150006, FDA-2016-M-2185 | Vasorum, Ltd | Celt ACD Vascular Closure Device | 7/20/2016 |
| P160004, FDA-2016-M-2332 | W.L. Gore & Associates, Inc | Gore TIGRIS Vascular Stent | 7/27/2016 |
| P150003/S003, FDA-2016-M-2334 | Boston Scientific Corp | SYNERGY TM Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-Wire & Monorail) | 7/29/2016 |
| P150037, FDA-2016-M-2333 | Alcon Laboratories, Inc | CyPass® System (Model 241-S) | 7/29/2016 |
| P150001, FDA-2016-M-2500 | Medtronic MiniMed | MiniMed 630G System with SmartGuard | 8/10/2016 |
| P150036, FDA-2016-M-2485 | Edwards Lifesciences, LLC | Edwards INTUITY Elite Valve System | 8/12/2016 |
| P130009/S057, FDA-2016-M-2498 | Edwards Lifesciences LLC | Edwards SAPIEN XT Transcatheter Heart Valve | 8/18/2016 |
| P140031/S010, FDA-2016-M-2499 | Edwards Lifesciences LLC | Edwards SAPIEN 3 Transcatheter Heart Valve | 8/18/2016 |
| P020045/S073, 2016-M-2649 | Medtronic, Inc | Freezor® Xtra Cardiac Cryoablation Catheter | 8/31/2016 |
| P140010/S015, FDA-2016-M-2650 | Medtronic Vascular, Inc | In Pact TM Admiral TM Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter | 9/7/2016 |
| P160001, FDA-2016-M-2651 | Obalon Therapeutics, Inc | Obalon Balloon System | 9/8/2016 |
| P150040, FDA-2016-M-2735 | Carl Zeiss Meditec, Inc | VisuMax® Femtosecond Laser | 9/13/2016 |
| 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 Glucose Monitoring System | 9/23/2016 |
| P080020/S020, FDA-2016-M-2975 | Seikagaku Corp | Gel-One® | 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, Inc | cobas® EGFR Mutation Test v2 | 9/28/2016 |
| P150030, FDA-2016-M-3430 | Smith & Nephew, Inc | R3 TM delta Ceramic Acetabular System | 10/17/2016 |
| P160006, FDA-2016-M-3431 | Ventana Medical Systems, Inc | VENTANA PD-L1 (SP142) Assay | 10/18/2016 |
| 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 | Amplatzer TM 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 System and iDesign Advanced WaveScan Studio | 11/14/2016 |
| P020050/S023, FDA-2016-M-4046 | Alcon Laboratories, Inc | WaveLight® EX500 and ALLEGRETTO WAVE® EYE-Q Excimer Laser Systems | 11/21/2016 |
| P140029, FDA-2016-M-4344 | Q-Med AB | Restylane® Refyne and Restylane® Defyne | 12/9/2016 |
| P130007/S016, FDA-2016-M-4458 | Animas Corporation | OneTouch Vibe TM Plus System | 12/16/2016 |
| P160018, FDA-2016-M-4459 | Foundation Medicine, Inc | FoundationFocus TM CDx BRACA Assay | 12/19/2016 |
| P120005/S041, FDA-2016-M-4483 | Dexcom, Inc | Dexcom G5 Mobile Continuous Glucose Monitoring System | 12/20/2016 |
| P040020/S049, FDA-2016-M-4657 | Alcon Laboratories, Inc | Acrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens | 12/22/2016 |
| P160019, FDA-2016-M-4530 | Roche Diagnostics | Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg II | 12/23/2016 |
| P100022/S020, FDA-2016-M-4653 | Cook Medical Inc | Zilver PTX Drug-Eluting Peripheral Stent | 12/28/2016 |
| H070005, FDA-2017-M-0180 | AGA Medical Corp | AMPLATZER TM Post-Infarct Muscular VSD Occluder | 1/10/2017 |
| P160031, FDA-2017-M-0181 | FUJIFILM Medical Systems U.S.A., Inc | ASPIRE Cristalle Digital Breast Tomosynthesis Option | 1/10/2017 |
| P160008, FDA-2017-M-0229 | HeartSine Technologies LLC | HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public Access Automated External Defibrillators, Accessories and Saver EVO® Software Version 1.4.0 | 1/12/2017 |
| P160021, FDA-2017-M-0560 | W.L. Gore & Associates, Inc | Gore® Viabahn® VBX Balloon Expandable Endoprosthesis | 1/27/2017 |
| P130024/S009, FDA-2017-M-0831 | Lutonix, Inc | Lutonix® 035 Drug Coated Balloon PTA Catheter | 2/7/2017 |
| P140033, FDA-2017-M-0661 | St. Jude Medical, Inc | MR Conditional Pacemaker System-Assurity MRI TM and Endurity MRI TM Pacemakers and Tendril MRI TM 1200M LPA Lead | 1/31/2017 |
| P160023, FDA-2017-M-0971 | Hologic, Inc | Aptima® HCV Quant Dx Assay | 2/13/2017 |
| P160003, FDA-2016-M-2652 | Biotronik, Inc | PRO-Kinetic Energy Cobalt Chromium Coronary Stent System | 2/14/2017 |
| P150039, FDA-2017-M-1121 | Tryton Medical, Inc | TRYTON Side Branch Stent | 2/21/2017 |
| P160014, FDA-2017-M-1122 | CeloNova BioSciences, Inc | COBRA PzF TM NanoCoated Coronary Stent System | 2/21/2017 |
| P100044/S023, FDA-2017-M-1228 | Intersect ENT | PROPEL® Contour Sinus Implant | 2/23/2017 |
| P140017/S005, FDA-2017-M-1227 | Medtronic, Inc | Melody TM Transcatheter Pulmonary Valve, Ensemble TM Transcatheter Valve Delivery System and Ensemble TM II Transcatheter Valve Delivery System | 2/24/2017 |
| P160016, FDA-2017-M-1713 | Siemens Healthcare Diagnostics, Inc | VERSANT® HCV GENOTYPE 2.0 Assay (LiPA) | 3/14/2017 |
| P110033/S020, FDA-2017-M-1714 | Allergan | Juvéderm Vollure TM XC | 3/17/2017 |
| P160025, FDA-2017-M-1845 | Biotronik, Inc | Astron Pulsar and Pulsar-18 Stent Systems | 3/23/2017 |
| P160009, FDA-2017-M-1950 | iCAD, Inc | PowerLook® Tomo Detection Software | 3/24/2017 |
| P160024, FDA-2017-M-2594 | Bard Peripheral Vascular, Inc | LifeStream Balloon Expandable Vascular Covered Stent | 4/24/2017 |
| P160043, FDA-2017-M-2767 | Medtronic, Inc | Resolute Onyx Zotarolimus- Eluting Coronary Stent System | 4/28/2017 |
| P160040, FDA-2017-M-2766 | Invivoscribe Technologies, Inc | LeukoStrat® CDx FLT3 Mutation Assay | 4/28/2017 |
| P160046, FDA-2017-M-2768 | Ventana Medical Systems, Inc | VENTANA PD-L1 (SP263) Assay | 5/1/2017 |
| H150003, FDA-2017-M-3103 | Wilson-Cook Medical, Inc | Flourish TM Pediatric Esophageal Atresia Device | 5/12/2017 |
| P160044, FDA-2017-M-3200 | Abbott Molecular, Inc | Abbott RealTime CMV | 5/18/2017 |
| P160041, FDA-2017-M-3430 | Roche Molecular Systems, Inc | cobas® CMV | 6/1/2017 |
| P140031/S028, FDA-2017-M-3579 | Edwards Lifesciences LLC | Edwards SAPIEN 3 TM Transcatheter Heart Valve and Accessories | 6/5/2017 |
| P160035, FDA-2017-M-3580 | Berlin Heart, Inc | EXCOR® Pediatric Ventricular Assist Device | 6/6/2017 |
| P160047, FDA-2017-M-3778 | AEGEA Medical, Inc | AEGEA Vapor System TM | 6/14/2017 |
| H160002, FDA-2017-M-3839 | Pulsar Vascular, Inc | PulseRider® Aneurysm Neck Reconstruction Device ("PulseRider") | 6/19/2017 |
| P160045, FDA-2017-M-3928 | Life Technologies Corp | Oncomine TM 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 Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve | 6/29/2017 |
| P160038, FDA-2017-M-3983 | Illumina, Inc | Praxis TM 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