PMA P110035
- Device
- Epic™ Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S068
- Product code
- NIO
- Decision date
- 2026-05-06
- Generic name
- STENT, ILIAC
- Approval order statement
- the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization
Current openFDA PMA Record#
- Device
- Epic™ Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S076
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2026-05-06
- Decision code
- OK30
- Date received
- 2026-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization