Zilver Vena Venous Self-Expanding Stent
FDA premarket approval P200023 · decided 2020-10-09
Approval details
- PMA number
- P200023
- Trade name
- Zilver Vena Venous Self-Expanding Stent
- Generic name
- Stent, iliac vein
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2020-04-13
- Decision date
- 2020-10-09
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic iliofemoral venous outflow obstruction.
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