{"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/2013/01/07/2013-00004.html","cfr_references":[],"citation":"78 FR 950","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket Nos. FDA-2012-M-0712, FDA-2012-M-0713, FDA-2012-M-0734, FDA-2012-M-0735, FDA-2012-M-0814, FDA-2012-M-0833, FDA-2012-M-0893, FDA-2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013"],"dockets":[],"document_number":"2013-00004","effective_on":null,"end_page":951,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/01/07/2013-00004.xml","html_url":"https://www.federalregister.gov/documents/2013/01/07/2013-00004/medical-devices-availability-of-safety-and-effectiveness-summaries-for-premarket-approval","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-00004?publication_date=2013-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-01-07/2013-00004/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":154,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-01-07/pdf/2013-00004.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-00004.pdf?1357307342","publication_date":"2013-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/01/07/2013-00004.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-2012-M-0713","supporting_documents_count":0,"docket_id":"FDA-2012-M-0713","regulation_id_number":null,"title":"Roche Molecular Systems, Inc., Premarket Approval of COBAS ® AmpliPrep/COBAS® TaqMan® CMV Test P110037, Approved 7/5/12","checked_regulationsdotgov_at":"2013-02-19T17:35:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":950,"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":78}