- Device
- WALLSTENT™ Venous Endoprosthesis with Unistep™ Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S067
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2026-05-06
- Decision code
- OK30
- Date received
- 2026-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization