{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.","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/2017/07/27/2017-15786.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"82 FR 34850","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective July 27, 2017. The classification was applicable on June 11, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-1916"],"dockets":[],"document_number":"2017-15786","effective_on":"2017-07-27","end_page":34852,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/07/27/2017-15786.xml","html_url":"https://www.federalregister.gov/documents/2017/07/27/2017-15786/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-15786?publication_date=2017-07-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-07-27/2017-15786/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1036,"last_updated":"2026-06-27 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-07-27/pdf/2017-15786.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-15786.pdf?1501073155","publication_date":"2017-07-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/07/27/2017-15786.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-2017-N-1916","supporting_documents_count":0,"docket_id":"FDA-2017-N-1916","regulation_id_number":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter","checked_regulationsdotgov_at":"2017-08-16T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":34850,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter","toc_doc":"Cardiovascular Devices; Classification of Balloon Aortic Valvuloplasty Catheter","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":82}