Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization除颤器/心脏复律器/起搏器,植入式,再同步

This profile provides complete Hong Kong MDACS registration information for Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization

產品資訊： 除颤器/心脏复律器/起搏器,植入式,再同步

Device Overview

Hong Kong MDACS registration summary and classification details.

Risk Class

Product Code

20376

Product Code Detail

20376 Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization

State

current

Status

N/A

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Pricing

Manufacturer (製造商)

Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation

Boston Scientific

United States

美国

4100 Hamline Aveenue North, St Paul, Minnesota, 55112-5798, USA

4100 Hamline Aveenue North, 圣保罗, 明尼苏达州, 55112-5798, 美国

Authorised Representative (AR)

Boston Scientific Hong Kong Limited

29607100

Regulatory Timeline

Registration Date

July 26, 2024

Expiry Date

July 25, 2029

Product Models

RESONATE X4 CRT-D (G447), RESONATE EL ICD (D432, D433), MOMENTUM CRT-D (G124, G125, G126), MOMENTUM X4 CRT-D (G138), MOMENTUM EL ICD (D120, D121), CHARISMA CRT-D (G325), CHARISMA X4 CRT-D (G347), CHARISMA EL ICD (D332, D333), VIGILIANT EL ICD (D232, D233), PERCIVA ICD (D400, D401, D412, D413), VIGILIANT X4 CRT-D (G247)

共振 X4 CRT-D (G447), 共振 ICD (D432, D433), 动量 CRT-D (G124, G125, G126), 动量 X4 CRT-D (G138), 动量 ICD (D120, D121), 魅力 CRT-D (G325), 魅力 X4 CRT-D (G347), 魅力 ICD (D332, D333), 活力 ICD (D232, D233), PERCIVA ICD (D400, D401, D412, D413), 活力 X4 CRT-D (G247)