PMA P930031S074

Device: Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System
Applicant: Boston Scientific Corp
PMA number: P930031
Supplement: S074
Product code: MIR
Decision date: 2024-02-20
Classification: Cardiovascular
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement: an alternate supplier of an ingredient used to make the resin for the tapered tips and luer connector of all Wallstent delivery systems

Current openFDA PMA Record

Device: Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System
Applicant: Boston Scientific Corp
PMA number: P930031
Supplement: S074
Product code: MIR
Generic name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date: 2024-02-20
Decision code: APPR
Date received: 2023-09-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternate supplier of an ingredient used to make the resin for the tapered tips and luer connector of all Wallstent delivery systems