VICI VENOUS STENT System and VICI RDS Stent System
FDA premarket approval P180013/S006 · decided 2021-02-11
Approval details
- PMA number
- P180013
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VICI VENOUS STENT System and VICI RDS Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-07-22
- Decision date
- 2021-02-11
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for the transfer of the finished device manufacturing site from Fremont, California to Galway, Ireland, the addition of new sterilization sites and cycles, and a change in legal manufacturer from Veniti, Inc. to Boston Scientific Corporation.
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