VICI VENOUS STENT System
FDA premarket approval P180013/S002 · decided 2020-09-15
Approval details
- PMA number
- P180013
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VICI VENOUS STENT System
- Generic name
- Stent, iliac vein
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-11-18
- Decision date
- 2020-09-15
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for a manufacturing site located at Confluent Medical, Free Zone and Business Park El Coyol, Building B14 Alajuela, Costa Rica for VICI stent component manufacturing.
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