{"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 Dockets Management Staff.","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/2018/05/22/2018-10924.html","cfr_references":[],"citation":"83 FR 23686","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-3372-0002","comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:20:47.858-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-3372-0002","allow_late_comments":true,"id":"FDA-2017-M-3372-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-3372","title":"Premarket Approval for Zoll Medical Corporation  AED Plus® and Fully Automatic AED Plus® Approved 5/26/17 - P160015"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:48.032-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-3951-0002","allow_late_comments":null,"id":"FDA-2017-M-3951-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-3951","title":"Premarket Approval for Cyberonics, Inc., Vagus Nerve Stimulation therapy System, Approved 6/23/2017, P970003/S207"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:52.693-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-3990-0003","allow_late_comments":null,"id":"FDA-2017-M-3990-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-3990","title":"Premarket Approval for Edwards Lifesciences, LLC Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve Approved 6/29/17"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:49.192-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-4022-0002","allow_late_comments":null,"id":"FDA-2017-M-4022-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-4022","title":"Premarket Approval for AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System, Approved, 6/30/2017\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:16.156-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-4271-0002","allow_late_comments":false,"id":"FDA-2017-M-4271-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-4271","title":"P130021/S033 -edtronic CoreValve LLC Medtronic CoreValve™ System, Medtronic oreValve™ Evolut™ R System and Medtronic CreValve™ Evolut™ PRO Approved 7/10/2017"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:50.397-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-4498-0002","allow_late_comments":null,"id":"FDA-2017-M-4498-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-4498","title":"Premarket Approval for Spectranetics Corp.  Stellarex 0.035” OTW Drug-coated Angioplasty Balloon Approved, 7/26/2017, P160049\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:09.353-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-4756-0002","allow_late_comments":null,"id":"FDA-2017-M-4756-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-4756","title":"Premarket Approval for Medtronic, Inc. Avalus Bioprosthesis Approved 7/31/17, P170006\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:08.202-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-4904-0002","allow_late_comments":null,"id":"FDA-2017-M-4904-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-4904","title":"Premarket Approval for Boston Scientific Neuromodulation Corporation Precision™ Spinal Cord Stimulator System Precision Spectra™ Spinal Cord Stimulator System Precision Novi™ Spinal Cord Stimulator System Precision™ Montage™ MRI Spinal Cord Stimulator "},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:05.872-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5262-0002","allow_late_comments":null,"id":"FDA-2017-M-5262-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5262","title":"Premarket Approval for Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Approved 8/25/17, P140015/S020"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:46.890-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5320-0002","allow_late_comments":null,"id":"FDA-2017-M-5320-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5320","title":"Premarket Approval for Thoratec Corporation HeartMate 3™ Left Ventricular Assist System Approved 8/23/2017, P160054"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:07.049-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5334-0002","allow_late_comments":null,"id":"FDA-2017-M-5334-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5334","title":"Premarket Approval for Lutonix, Inc. Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010 Approved 8/25/2017; P170003"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:53.842-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5438-0002","allow_late_comments":null,"id":"FDA-2017-M-5438-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5438","title":"Premarket Approval for Bioventus LLC DUROLANE®  Approved 8/29/2017, P170007"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:54.229-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5863-0002","allow_late_comments":null,"id":"FDA-2017-M-5863-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5863","title":"Premarket Approval for ZEUS Scientific, Inc. ZEUS ELISA Parvovirus B19 IgM Test System Approved 9/19/17; P150042\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:55.370-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5884-0002","allow_late_comments":null,"id":"FDA-2017-M-5884-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5884","title":"Premarket Approval for ABIOMED, Inc. Impella RP® System Approved 7/20/2017; P170011\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:03.555-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5929-0002","allow_late_comments":null,"id":"FDA-2017-M-5929-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5929","title":"Premarket Approval for Dako North America, Inc. PD-L1 IHC 22C3  pharmDx; Approved 9/22/2017; P150013/S006"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:56.532-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5969-0002","allow_late_comments":null,"id":"FDA-2017-M-5969-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5969","title":"Premarket Approval for Abbott Diabetes Care, Inc. Freestyle Libre Flash Glucose Monitoring System Approved 9/27/2017; P160030"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:57.689-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-5997-0002","allow_late_comments":null,"id":"FDA-2017-M-5997-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-5997","title":"Premarket Approval for Medtronic Vascular EndurantII / Endurant IIs Stent Graft System Approved 9/29/2017; P100021/S063"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:58.866-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6223-0002","allow_late_comments":null,"id":"FDA-2017-M-6223-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6223","title":"Premarket Approval for Respicardia, Inc. remedē® System, Approved 10/6/2017, P160039\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:18:51.532-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6232-0002","allow_late_comments":null,"id":"FDA-2017-M-6232-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6232","title":"Premarket Approval for Teoxane S.A. RHA® 2, RHA® 3 and RHA® 4 Approved 10/19/2017, P170002\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:04.708-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6290-0002","allow_late_comments":null,"id":"FDA-2017-M-6290-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6290","title":"Premarket Approval for NiMED, Inc. Cheatham Platinum (CP) Stent System (Covered CP Stent and Covered Mounted CP Stent) approved 10/24/2017, P150028/S001\n\n"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:10.506-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6525-0002","allow_late_comments":null,"id":"FDA-2017-M-6525-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6525","title":"Premarket Approval for OrthogenRx, Inc. TriVisc, Approved 11/13/2017, P160057"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:11.649-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6550-0002","allow_late_comments":null,"id":"FDA-2017-M-6550-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6550","title":"Premarket Approval for Medtronic Vascular Resolute Onyx Zotarolimus Eluting Coronary Stent System, Approved 11/16/2017, P160043/S001"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:15.546-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6650-0002","allow_late_comments":false,"id":"FDA-2017-M-6650-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6650","title":"Premarket Approval for Medinol Ltd. EluNIR® Ridaforolimus Eluting Coronary Stent System Approved 11/28/2017, P170008"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:00.045-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6799-0002","allow_late_comments":null,"id":"FDA-2017-M-6799-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6799","title":"Premarket Approval for Foundation Medicine, Inc.  FoundationOne CDx, Approved 11/30/2017, P170019"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-05-22","updated_at":"2024-11-07T15:19:01.197-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-M-6800-0002","allow_late_comments":null,"id":"FDA-2017-M-6800-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-M-6800","title":"Premarket Approval for Boston Scientific Vercise™ Deep Brain Stimulation (DBS) System Approved 12/8/2017, P150031\n\n"}],"document_number":"2018-10924","effective_on":null,"end_page":23688,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/05/22/2018-10924.xml","html_url":"https://www.federalregister.gov/documents/2018/05/22/2018-10924/medical-devices-availability-of-safety-and-effectiveness-summaries-for-premarket-approval","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-10924?publication_date=2018-05-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-05-22/2018-10924/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1811,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-05-22/pdf/2018-10924.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-10924.pdf?1526906733","publication_date":"2018-05-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/05/22/2018-10924.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-2017-M-3372","supporting_documents_count":0,"docket_id":"FDA-2017-M-3372","document_id":"FDA-2017-M-3372-0002","regulation_id_number":null,"title":"Premarket Approval for Zoll Medical Corporation  AED Plus® and Fully Automatic AED Plus® Approved 5/26/17 - P160015","checked_regulationsdotgov_at":"2024-11-08T00:55:11Z"},"regulations_dot_gov_url":"https://www.regulations.gov/commenton/FDA-2017-M-3372-0002","significant":null,"signing_date":null,"start_page":23686,"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":83}