- Device
- Epic Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S056
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2020-05-05
- Decision code
- APPR
- Date received
- 2020-01-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a manufacturing site located at Synergy Health AST, SRL, in Alajuela, Costa Rica to perform contract sterilization.