PMA P980033S064

Device: Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S064
Product code: QKJ
Decision date: 2024-02-20
Classification: Cardiovascular
Generic name: Stent, central venous
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™ Venous Endoprosthesis with Unistep Plus™ Delivery System
Applicant: Boston Scientific Corporation
PMA number: P980033
Supplement: S064
Product code: QKJ
Generic name: Stent, central venous
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