Medical Device Division · registration 220187Active

St. Jude Medical

Name: St. Jude Medical — Medical Device Division 220187
Creator: St. Jude Medical
Keywords: St. Jude Medical, St. Jude Medical, 220187, Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic, Medical Device Division

Hong KongProstheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, AorticClass IVSt. Jude Medical

Verified

Official record identity

MDACS listing number: 220187
Model name: Navitor Transcatheter Heart Valve (NVTR-23, NVTR-25, NVTR-27, NVTR-29), Navitor Loading System (NVTR-LS-SM, NVTR-LS-LG), FlexNav Delivery System (FNAV-DS-SM, FNAV-DS-LG)
Registration date: June 29, 2022
Expiry date: June 29, 2027
Source update date: April 25, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic

Published parties

Registrant / registration holder: Abbott Medical (Hong Kong) Limited
Manufacturer: St. Jude Medical

Official description

Prostheses, Cardiac Valve, Biological, Tissue Leaflet, Transcatheter, Aortic

Additional source fields

AMD nomenclature code: 33937
Traditional Chinese local responsible person: 美國雅培醫療用品(香港)有限公司
Local responsible person phone: 29967688
Published manufacturer address: 177 County Road B East, St. Paul, Minnesota, 55117 USA

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.