Medical Device Division · registration 150086Active

Cardiac Pacemakers

Name: Cardiac Pacemakers — Medical Device Division 150086
Creator: Cardiac Pacemakers, Incorporated: a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Keywords: Cardiac Pacemakers, Cardiac Pacemakers, 150086, Pacemakers, Cardiac, Implantable, Medical Device Division

Hong KongPacemakers, Cardiac, ImplantableClass IVCardiac Pacemakers, Incorporated: a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation

Verified

Official record identity

MDACS listing number: 150086
Model name: ACCOLADE MRI (L310, L311, L331), ESSENTIO MRI (L110, L111, L131), ESSENTIO (L100, L101), PROPONENT MRI (L231), PROPONENT (L200, L221)
Registration date: March 03, 2025
Expiry date: April 29, 2030
Source update date: April 23, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Pacemakers, Cardiac, Implantable

Published parties

Registrant / registration holder: Boston Scientific Hong Kong Limited
Manufacturer: Cardiac Pacemakers, Incorporated: a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation

Official description

Pacemakers, Cardiac, Implantable

Additional source fields

AMD nomenclature code: 12913
Local responsible person phone: 29607100
Published manufacturer address: 4100 Hamline Avenue North, Saint 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.