Medical Device Division · registration 130314Expired

Boston Scientific

Name: Boston Scientific — Medical Device Division 130314
Creator: Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Keywords: Boston Scientific, Boston Scientific, 130314, 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: 130314
Model name: ACUITY Steerable Leads (4554, 4555), ACUITY Steerable Delivery Stylets (6490, 6690, 6491, 6691)
Registration date: August 03, 2018
Expiry date: August 30, 2023
Source update date: July 11, 2023
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, St Paul, Minnesota, 55112-5798, USA
Published remarks: Expired.
Revision number: b

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.