PMA P930031S070
- Device
- Wallstent™ TIPS Endoprosthesis with Unistep Plus™ Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P930031
- Supplement
- S070
- Product code
- MIR
- Decision date
- 2022-11-22
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Approval order statement
- Addition of an alternative heat seal coating to be used on the packaging.
Current openFDA PMA Record#
- Device
- Wallstent™ TIPS Endoprosthesis with Unistep Plus™ Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P930031
- Supplement
- S070
- Product code
- MIR
- Generic name
- SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
- Decision date
- 2022-11-22
- Decision code
- OK30
- Date received
- 2022-10-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative heat seal coating to be used on the packaging.