Taiwan FDA registration a56e2cba2e37e589a1e75f102ae3b7e7

"Gore" thoracic aortic aneurysm stent

TW: “戈爾”胸主動脈瘤支架
Taiwan flagTaiwan·Risk Class 3·W.L. GORE & ASSOCIATES INC.·Registered Mar 24, 2010 – Mar 24, 2020Cancelled
Registration details
Analysis ID
a56e2cba2e37e589a1e75f102ae3b7e7
Customs Code
DHA00602095800
Company information
Manufacturer Country
United States
Product details
Intended Use
This thoracic aortic aneurysm stent is used for endovascular repair of descending thoracic aortic aneurysms (DTA), and patients should have appropriate anatomy, including appropriate iliac/femoral access, aortic inner diameter within 23-37 mm, and aortic aneurysm without aortic aneurysm ≧ 2cm proximal and distal aneurysm.
Product Type (Level 1)
E Cardiovascular Medicine Science
Product Type (Level 2)
E.0001 Cardiovascular stents
Import Information
import
Dates and status
Registration Date
Mar 24, 2010
Expiry Date
Mar 24, 2020
Cancellation Date
Aug 05, 2022
Cancellation information
Status
Logged out
Reason
未展延而逾期者
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About this record

Access comprehensive regulatory information for "Gore" thoracic aortic aneurysm stent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number a56e2cba2e37e589a1e75f102ae3b7e7 and manufactured by W.L. GORE & ASSOCIATES INC.. The authorized representative in Taiwan is W.L. GORE & ASSOCIATES (HONG KONG) LTD. TAIWAN BRANCH (H.K.).

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