VICI VENOUS STENT System
FDA premarket approval P180013 · decided 2019-05-02
Approval details
- PMA number
- P180013
- Trade name
- VICI VENOUS STENT System
- Generic name
- Stent, iliac vein
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-04-26
- Decision date
- 2019-05-02
- Days to decision
- 371 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
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