140130
IV
current
Leads, Pacemaker, Implantable, Endocardialๅฏผ็บฟใ่ตทๆๅจใๆคๅ ฅๅผใๅฟๅ ่
This profile provides complete Hong Kong MDACS registration information for Leads, Pacemaker, Implantable, Endocardial. 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: Leads, Implantable Cardiac Pacemaker, Endocardial
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
12900
Product Code Detail
12900 Leads, Implantable Cardiac Pacemaker, Endocardial
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation
Boston Scientific
United States
็พๅฝ
4100 Hamline Avenue North, St Paul, Minnesota 55112-5798, USA
4100ๅๅงๆๅคง้ๅ,ๅฃไฟ็ฝ,ๆๅฐผ่่พพๅท55112-5798,็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 27, 2024
Expiry Date
May 26, 2029
Product Models
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)
ๆ้ๅบฆ X4 ็ดๅ (4671, 4672), ๆ้ๅบฆ X4 ่บๆ S (4674, 4675), ๆ้ๅบฆ X4 ่บๆ L (4677, 4678), ็ผๅๅฅ็ฎก (4603), ๆ้ๅบฆ X4 ่ฟๆฅๅจๅทฅๅ
ท (4625), ๆ้ๅบฆ X4 ๅฒๆดๅทฅๅ
ท/ๅฏผไธๅจ (4604)