Zilver Vena Venous Self-Expanding Stent

FDA Premarket Approval P200023 S001

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

Updates to the instructions for use

DeviceZilver Vena Venous Self-Expanding Stent
Generic NameStent, Iliac Vein
ApplicantCook Ireland Ltd.
Date Received2021-09-02
Decision Date2021-10-01
PMAP200023
SupplementS001
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Cook Ireland Ltd. o' Halloran Road, National Technology Park limerick 

Supplemental Filings

Supplement NumberDateSupplement Type
P200023Original Filing
S001 2021-09-02 Special (immediate Track)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.