Medical Device Division · registration 140130Active

Boston Scientific

Name: Boston Scientific — Medical Device Division 140130
Creator: Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Keywords: Boston Scientific, Boston Scientific, 140130, 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: 140130
Model name: Acuity X4 Straight (4671, 4672), Acuity X4 Spiral S (4674, 4675), Acuity X4 Spiral L (4677, 4678), Suture Sleeve (4603), Acuity X4 Connector Tool (4625), Acuity X4 Flushing Tool/Wire Guide (4604)
Registration date: May 27, 2024
Expiry date: May 26, 2029
Source update date: September 05, 2024
Status: Active

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
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.