{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti- anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order.","action":"Final order.","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/2013/12/30/2013-31216.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"78 FR 79304","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective December 30, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0487"],"dockets":[],"document_number":"2013-31216","effective_on":"2013-12-30","end_page":79308,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/12/30/2013-31216.xml","html_url":"https://www.federalregister.gov/documents/2013/12/30/2013-31216/cardiovascular-devices-reclassification-of-external-counter-pulsating-devices-for-treatment-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-31216?publication_date=2013-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-12-30/2013-31216/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1042,"last_updated":"2026-09-22 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-12-30/pdf/2013-31216.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-31216.pdf?1388152757","publication_date":"2013-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/12/30/2013-31216.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0487","supporting_documents_count":0,"docket_id":"FDA-2013-N-0487","regulation_id_number":null,"title":"Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina That Is Refractory to Optimal Antianginal Medical Therapy and Without Options for Revascularization; Effective Date of Requirement for Pr","checked_regulationsdotgov_at":"2014-01-19T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":79304,"subtype":null,"title":"Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses","toc_doc":"Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina, etc.","toc_subject":"Cardiovascular Devices:","topics":["Medical devices"],"type":"Rule","volume":78}