120438
IV
Expired.
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
็ขๅ่ณ่จ๏ผ ๅฏผ่็บฟใๆคๅ ฅๅผๅฟ่่ตทๆๅจใๅฟๅ ่
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
Expired.
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, Saint Paul, Minnesota, 55112-5798, USA
4100 Hamline Avenue North, ๅฃไฟ็ฝ, ๆๅฐผ่่พพๅท, 55112-5798, ็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
February 20, 2019
Expiry Date
December 31, 2022
Product Models
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)
็ง่ฑIIๅๅบ้ๅฏผ็บฟ(4456ใ4457ใ4458ใ4459ใ4479ใ4480)ใ็ง่ฑIIๅๅบ้EZๅฏผ็บฟ(4469ใ4470ใ4471ใ4472ใ4473ใ4474)ใ็ผๅๅฅ้ไปถๅฅไปถ(6220ใ6221)