Zilver Vena Venous Self-Expanding Stent

FDA Premarket Approval P200023

Pre-market Approval Supplement Details

Improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.

DeviceZilver Vena Venous Self-Expanding Stent
Generic NameStent, Iliac Vein
ApplicantCook Ireland Ltd.
Date Received2020-04-13
Decision Date2020-10-09
Product CodeQAN 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Cook Ireland Ltd. o' Halloran Road, National Technology Park limerick 

Supplemental Filings

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Supplement NumberDateSupplement Type
P200023Original Filing

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