Medical Device Division · registration 120438Expired

Boston Scientific

Name: Boston Scientific — Medical Device Division 120438
Creator: Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Keywords: Boston Scientific, Boston Scientific, 120438, Leads, Pacemaker, Implantable, Endocardial, Medical Device Division

Hong KongLeads, Pacemaker, Implantable, EndocardialClass 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: 120438
Model name: FINELINE II Sterox Leads (4456, 4457, 4458, 4459, 4479, 4480), FINELINE II Sterox EZ Leads (4469, 4470, 4471, 4472, 4473, 4474), Suture Sleeve Accessory Kit (6220, 6221)
Registration date: February 20, 2019
Expiry date: December 31, 2022
Source update date: December 15, 2020
Status: Expired

Classification

Risk class: Class IV
Published category: Leads, Pacemaker, Implantable, Endocardial

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

Leads, Implantable Cardiac Pacemaker, Endocardial

Additional source fields

AMD nomenclature code: 12900
Local responsible person phone: 29607100
Published manufacturer address: 4100 Hamline Avenue North, Saint 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.