federal_register: 2016-08898

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-08898 Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers Rule The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation. 2016-04-18 2016 4 https://www.federalregister.gov/documents/2016/04/18/2016-08898/cardiovascular-devices-reclassification-of-external-pacemaker-pulse-generator-devices https://www.govinfo.gov/content/pkg/FR-2016-04-18/pdf/2016-08898.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls)...  

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