PMA P110035S067
- Device
- Epic Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S067
- Product code
- NIO
- Decision date
- 2022-05-06
- Generic name
- STENT, ILIAC
- Approval order statement
- Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.
Current openFDA PMA Record#
- Device
- Epic Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S067
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2022-05-06
- Decision code
- OK30
- Date received
- 2022-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.