PMA P110035S075
- Device
- EPIC Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S075
- Product code
- NIO
- Decision date
- 2026-04-02
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- a replacement vision system for stent visual inspections, changes to the stent inspection flow and level of inspections
Current openFDA PMA Record#
- Device
- EPIC Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S075
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2026-04-02
- Decision code
- OK30
- Date received
- 2026-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a replacement vision system for stent visual inspections, changes to the stent inspection flow and level of inspections