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Medical Device Division · registration 120437Expired

Boston Scientific

Hong KongLeads, Pacemaker, Implantable, EndocardialClass IVCardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Official record identity
MDACS listing number
120437
Model name
Flextend 2 (4095, 4096, 4097), Terminal pin fixation tool (6616)
Registration date
May 03, 2018
Expiry date
December 31, 2022
Source update date
December 15, 2020
Status
Expired
Classification
Risk class
Class IV
Official value: IV
Published category
Leads, Pacemaker, Implantable, Endocardial
Published parties
Registrant / registration holder
Boston Scientific Hong Kong Limited
Official description

Leads, Implantable Cardiac Pacemaker, Endocardial

Additional source fields
AMD nomenclature code
12900
Local responsible person phone
29607100
Published manufacturer address
4100 Hamline Avenue North, St Paul, Minnesota 55112-5798, USA
Published remarks
Expired.
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.