Medical Device Division · registration 220022Active

St. Jude Medical

Name: St. Jude Medical — Medical Device Division 220022
Creator: St. Jude Medical Cardiac Rhythm Management Division
Keywords: St. Jude Medical, St. Jude Medical, 220022, Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization, Medical Device Division

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

Verified

Official record identity

MDACS listing number: 220022
Model name: Avant VR (CDVRA700Q), Gallant VR (CDVRA500Q), Entrant VR (CDVRA300Q), Neutrino NxT VR (CDVRA800Q, CDVRA600Q), Avant DR (CDDRA700Q), Gallant DR (CDDRA500Q), Entrant DR (CDDRA300Q), Neutrino NxT DR (CDDRA800Q, CDDRA600Q), Avant HF (CDHFA700Q), Gallant HF (CDHFA500Q), Entrant HF (CDHFA300Q), Neutrino NxT HF (CDHFA800Q, CDHFA600Q)
Registration date: January 20, 2022
Expiry date: January 20, 2027
Source update date: October 25, 2024
Status: Active

Classification

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

Published parties

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

Official description

Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization

Additional source fields

AMD nomenclature code: 20376
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

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.