VICI VENOUS STENT System
FDA premarket approval P180013/S004 · decided 2020-09-03
Approval details
- PMA number
- P180013
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VICI VENOUS STENT System
- Generic name
- Stent, iliac vein
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-03-10
- Decision date
- 2020-09-03
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for the second stent delivery system the VICI RDS Venous Stent System.
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