Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | Zilver Vena Venous Self-Expanding Stent |
Generic Name | Stent, iliac vein |
Applicant | Cook Ireland Ltd. O' Halloran Road, National Technology Park Limerick |
PMA Number | P200023 |
Date Received | 04/13/2020 |
Decision Date | 10/09/2020 |
Product Code |
QAN |
Docket Number | 20M-2068 |
Notice Date | 10/13/2020 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01663051
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Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 |
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