Medical Device Division · registration 130441Active

St. Jude Medical

Name: St. Jude Medical — Medical Device Division 130441
Creator: St. Jude Medical Cardiac Rhythm Management Division
Keywords: St. Jude Medical, St. Jude Medical, 130441, Defibrillator/Cardioverter/Pacemakers, Implantable, Medical Device Division

Hong KongDefibrillator/Cardioverter/Pacemakers, ImplantableClass IVSt. Jude Medical Cardiac Rhythm Management Division

Verified

Official record identity

MDACS listing number: 130441
Model name: Fortify Assura VR (CD1359‐40C, CD1359‐40QC), Fortify Assura DR (CD2359‐40C, CD2359‐40QC), Ellipse VR (CD1377‐36C, CD1377‐36QC), Ellipse DR (CD2377‐36C, CD2377‐36QC)
Registration date: July 26, 2023
Expiry date: December 13, 2028
Source update date: October 25, 2024
Status: Active

Classification

Risk class: Class IV
Published category: Defibrillator/Cardioverter/Pacemakers, Implantable

Published parties

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

Official description

Defibrillator/Cardioverter/Pacemakers, Implantable

Additional source fields

AMD nomenclature code: 18504
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: 15900 Valley View Court, Sylmar, CA 91342, USA
Revision number: c

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.