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Medical Device Division · registration 130492Active

Boston Scientific

Hong KongLeads, Implantable DefibrillatorClass IVCardiac Pacemakers Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Official record identity
MDACS listing number
130492
Model name
RELIANCE 4-FRONT Active Fixation (0672, 0673, 0652, 0675, 0676, 0653, 0692, 0693, 0657, 0695, 0696, 0658), RELIANCE 4-FRONT Passive Fixation (0662, 0663, 0650, 0665, 0636, 0651, 0682, 0683, 0654, 0685, 0686, 0655), Suture Sleeve (6403)
Registration date
December 31, 2023
Expiry date
December 30, 2028
Source update date
July 15, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Leads, Implantable Defibrillator
Published parties
Registrant / registration holder
Boston Scientific Hong Kong Limited
Official description

Leads, Implantable Defibrillator

Additional source fields
AMD nomenclature code
16653
Local responsible person phone
29607100
Published manufacturer address
4100 Hamline Avenue North, St Paul, Minnesota, 55112-5798, 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.