PMA P930031S072
- Device
- WALLSTENT™ TIPS Endoprosthesis with Unistep Plus™ Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P930031
- Supplement
- S072
- Product code
- MIR
- Decision date
- 2023-06-14
- Classification
- Cardiovascular
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- Upgrading the control system for the furnace system at the Boston Scientific Corporation (BSC) Galway facility.
Current openFDA PMA Record#
- Device
- WALLSTENT™ TIPS Endoprosthesis with Unistep Plus™ Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P930031
- Supplement
- S072
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2023-06-14
- Decision code
- OK30
- Date received
- 2023-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrading the control system for the furnace system at the Boston Scientific Corporation (BSC) Galway facility.