Medical Device Division · registration 190250ActiveCardiac Pacemakers
Hong KongDefibrillator/Cardioverter/Pacemakers, Implantable, ResynchronizationClass IVCardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Official record identity
- MDACS listing number
- 190250
- Model name
- RESONATE X4 CRT-D (G447), RESONATE EL ICD (D432, D433), MOMENTUM CRT-D (G124, G125, G126), MOMENTUM X4 CRT-D (G138), MOMENTUM EL ICD (D120, D121), CHARISMA CRT-D (G325), CHARISMA X4 CRT-D (G347), CHARISMA EL ICD (D332, D333), VIGILIANT EL ICD (D232, D233), PERCIVA ICD (D400, D401, D412, D413), VIGILIANT X4 CRT-D (G247)
- Registration date
- July 26, 2024
- Expiry date
- July 25, 2029
- Source update date
- March 31, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization
Official value: IV
Published parties
- Registrant / registration holder
- Boston Scientific Hong Kong Limited
Official description
Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization
Additional source fields
- AMD nomenclature code
- 20376
- Local responsible person phone
- 29607100
- Published manufacturer address
- 4100 Hamline Aveenue North, St Paul, Minnesota, 55112-5798, USA
- Revision number
- a
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.