Zilver Vena Venous Self-Expanding Stent

FDA Premarket Approval P200023 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for adding a manufacturing site for delivery system tips and process changes for inner catheters

DeviceZilver Vena Venous Self-Expanding Stent
Generic NameStent, Iliac Vein
ApplicantCook Ireland Ltd.
Date Received2021-09-27
Decision Date2021-10-26
PMAP200023
SupplementS002
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cook Ireland Ltd. o' Halloran Road, National Technology Park limerick 

Supplemental Filings

Supplement NumberDateSupplement Type
P200023Original Filing
S002 2021-09-27 30-day Notice
S001 2021-09-02 Special (immediate Track)

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