PMA P930031
- Device
- Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P930031
- Supplement
- S071
- Product code
- MIR
- Decision date
- 2024-06-27
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- a new automated cleaning system at your component supplier
Current openFDA PMA Record#
- Device
- Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P930031
- Supplement
- S076
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2024-06-27
- Decision code
- OK30
- Date received
- 2024-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new automated cleaning system at your component supplier