{"abstract":"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.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/02/09/2016-02522.html","cfr_references":[],"citation":"81 FR 6865","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:46.319-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3256-0002","allow_late_comments":null,"id":"FDA-2015-M-3256-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3256","title":"Premarket Approval for Fidia Farmaceutici, S.p.A. HYMOVIS®, Approved 8/28/15, P150010"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:35.612-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3257-0002","allow_late_comments":null,"id":"FDA-2015-M-3257-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3257","title":"Premarket Approval for - Biomimetic Therapeutics, LLC Augment® Bone Graft Approved 9/1/15, P100006 "},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:27.400-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3258-0002","allow_late_comments":null,"id":"FDA-2015-M-3258-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3258","title":"Premarket Approval for OrthogenRx, Inc. GenVisc 850,  Approved 9/2/15, P140005\n\n"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:42.354-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3376-0002","allow_late_comments":null,"id":"FDA-2015-M-3376-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3376","title":"Premarket Approval for Tandem Diabetes Care, Inc. t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, Approved 9/8/15, P140015"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:40.579-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3377-0002","allow_late_comments":null,"id":"FDA-2015-M-3377-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3377","title":"Premarket Approval for Cook Medical Inc., Zenith Alpha™ Thoracic Endovascular Graft, Approved 9/15/15, P140016"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:33.420-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3516-0002","allow_late_comments":null,"id":"FDA-2015-M-3516-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3516","title":"Premarket Approval for Abbott Vascular XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System, XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus E"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:42.814-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3519-0002","allow_late_comments":null,"id":"FDA-2015-M-3519-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3519","title":"Premarket Approval for Allergan Juvederm Ultra XC, Approved 9/30/15, P050047/S044 "},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:28.664-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3520-0002","allow_late_comments":null,"id":"FDA-2015-M-3520-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3520","title":"Premarket Approval for Dako North America, Inc, LifeVest Wearable Cardioverter Defibrillator, Approved 10/2/15, P150043/S001"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:29.919-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-3521-0002","allow_late_comments":null,"id":"FDA-2015-M-3521-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-3521","title":"Premarket Approval for Zoll Lifecor Corp., LifeVest Wearable Cardioverter Defibrillator, Approved : Pening , P010030/S056 "},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:43.745-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4013-0002","allow_late_comments":null,"id":"FDA-2015-M-4013-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4013","title":"Premarket Approval for Medtronic, Inc., Minimed 530G System with Threshold Suspend featuring SmartGuard™ technology, Approved 10/2/15, P120010/S046"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:36.087-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4014-0002","allow_late_comments":null,"id":"FDA-2015-M-4014-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4014","title":"Premarket Approval for Boston Scientific Corporation SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System Approved 10/2/15, P150003"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:36.536-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4015-0002","allow_late_comments":null,"id":"FDA-2015-M-4015-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4015","title":"Premarket Approval for Novocure, Inc., Optune™ (formerly NovoTTF-100A™ System), Approved 10/5/15, P100034/S013"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:30.377-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4016-0002","allow_late_comments":null,"id":"FDA-2015-M-4016-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4016","title":"Premarket Approval for Dako North America, Inc., PD-L1 IHC 28-8 pharmDx, Approved 10/9/15, P150025"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:41.895-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4017-0002","allow_late_comments":null,"id":"FDA-2015-M-4017-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4017","title":"Premarket Approval for Edwards Lifesciences LLC, Edwards SAPIEM XT™ Transcatheter Heart Valve and accessories, Approved 10/9/15, P130009/S034"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:33.862-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4018-0002","allow_late_comments":null,"id":"FDA-2015-M-4018-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4018","title":"Premarket Approval for Roche Molecular Systems, Inc., cobas® HCV, Approved 10/14/15, P150015"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:35.104-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4069-0002","allow_late_comments":null,"id":"FDA-2015-M-4069-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4069","title":"Premarket Approval for Roche Molecular Systems , Inc., cobas® HBV, Approved 10/14/15, P150014"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:45.035-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4343-0002","allow_late_comments":null,"id":"FDA-2015-M-4343-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4343","title":"Premarket Approval for Cerapedics, Inc., i-FACTOR ® Peptide Enhanced Bone Graft Approved 11/3/15, P140019"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:43.270-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4344-0002","allow_late_comments":null,"id":"FDA-2015-M-4344-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4344","title":"Premarket Approval for Roche Molecular Systems, Inc., cobas® EGFR Mutation Test v2, Approved 11/13/15, 120019/S007"},{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:31.659-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4434-0002","allow_late_comments":null,"id":"FDA-2015-M-4434-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4434","title":"Premarket Approval for Algostim., LLC Algovita Spinal Cord Stimulation System Approved 11/20/15 P130028"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:37.839-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4728-0002","allow_late_comments":null,"id":"FDA-2015-M-4728-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4728","title":"Premarket Approval for Medtronic MiniMed, Paradigm REAL-Time Revel System, Approved 12/7/15, P150019"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:32.138-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4947-0002","allow_late_comments":null,"id":"FDA-2015-M-4947-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4947","title":"Premarket Approval for Biotronik, Inc. Astron Peripheral Self-Expanding Nitinol Stent System, Approved 12/17/15, P140030"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2016-02-09","updated_at":"2023-03-01T13:21:39.249-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-M-4951-0002","allow_late_comments":null,"id":"FDA-2015-M-4951-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-M-4951","title":"Premarket Approval for Seikagaku Corporation, VISCO-3, Approved 12/21/15, P980044/S027"}],"document_number":"2016-02522","effective_on":null,"end_page":6866,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/02/09/2016-02522.xml","html_url":"https://www.federalregister.gov/documents/2016/02/09/2016-02522/medical-devices-availability-of-safety-and-effectiveness-summaries-for-premarket-approval","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-02522?publication_date=2016-02-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-02-09/2016-02522/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":204,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-02-09/pdf/2016-02522.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-02522.pdf?1454939209","publication_date":"2016-02-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/02/09/2016-02522.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-M-3258","supporting_documents_count":0,"docket_id":"FDA-2015-M-3258","document_id":"FDA-2015-M-3258-0002","regulation_id_number":null,"title":"Premarket Approval for OrthogenRx, Inc. GenVisc 850,  Approved 9/2/15, P140005\n\n","checked_regulationsdotgov_at":"2023-03-01T18:21:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6865,"subtype":null,"title":"Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications","toc_doc":"Safety and Effectiveness Summaries for Premarket Approval Applications","toc_subject":"Medical Devices:","topics":[],"type":"Notice","volume":81}