{"abstract":"The Food and Drug Administration (FDA) is announcing its approval of the application by Johnson and Johnson Interventional Systems Co., Warren, NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of PALMAZ-SCHATZTM Balloon-Expandable Stent. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of August 2, 1994, of the approval of the application. In addition, the PALMAZ- SCHATZTM Balloon-Expandable Stent requires tracking under the act as amended by the Safe Medical Devices Act of 1990.","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/1997/07/10/97-17975.html","cfr_references":[],"citation":"62 FR 37067","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Petitions for administrative review by August 11, 1997.","disposition_notes":null,"docket_ids":["Docket No. 97M-0166"],"dockets":[],"document_number":"97-17975","effective_on":null,"end_page":37068,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/07/10/97-17975/johnson-and-johnson-interventional-systems-co-premarket-approval-of-palmaz-schatzsuptmsup","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-17975?publication_date=1997-07-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-07-10/97-17975/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":63,"last_updated":"2024-03-28 12:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-07-10/pdf/97-17975.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-07-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/07/10/97-17975.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37067,"subtype":null,"title":"Johnson and Johnson Interventional Systems Co.; Premarket Approval of PALMAZ-SCHATZSUPTM/SUP Balloon-Expandable Stent","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":62}