Medical Device Division · registration 120286Cancelled

St. Jude Medical

Name: St. Jude Medical — Medical Device Division 120286
Creator: St. Jude Medical, Cardiac Rhythm Management Division
Keywords: St. Jude Medical, St. Jude Medical, 120286, Pacemakers, Cardiac, Medical Device Division

Hong KongPacemakers, CardiacClass IVSt. Jude Medical, Cardiac Rhythm Management Division

Verified

Official record identity

MDACS listing number: 120286
Model name: Implantable Pacemaker Systems with a conditional intended use in a MRI environment (Accent MRI (PM1124, PM2124), Accent ST MRI (PM1126, PM2126))
Registration date: August 14, 2012
Source update date: July 15, 2025
Status: Cancelled

Classification

Risk class: Class IV
Published category: Pacemakers, Cardiac

Published parties

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

Official description

Pacemakers, Cardiac

Additional source fields

AMD nomenclature code: 12911
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.
Published remarks: Delisted.
Delist date: 2018-09-17

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.