PMA P110035S068
- Device
- EPIC Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S068
- Product code
- NIO
- Decision date
- 2022-11-07
- Generic name
- STENT, ILIAC
- Approval order statement
- Move portions of the component level manufacturing into a new building at the Maple Grove, Minnesota BSC site.
Current openFDA PMA Record#
- Device
- EPIC Vascular Self-Expanding Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P110035
- Supplement
- S068
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2022-11-07
- Decision code
- OK30
- Date received
- 2022-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move portions of the component level manufacturing into a new building at the Maple Grove, Minnesota BSC site.