PMA P110035S074
- Device
- Epic™ Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S074
- Product code
- NIO
- Decision date
- 2025-08-08
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- an alternate supplier of a delivery system component
Current openFDA PMA Record#
- Device
- Epic™ Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S074
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-08-08
- Decision code
- OK30
- Date received
- 2025-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate supplier of a delivery system component