PMA P980033S061
- Device
- WALLSTENT™ Venous Endoprosthesis with Unistep Plus™ Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S061
- Product code
- QKJ
- Decision date
- 2022-11-28
- Generic name
- Stent, central venous
- Approval order statement
- New method for water bath sterilization.
Current openFDA PMA Record#
- Device
- WALLSTENT™ Venous Endoprosthesis with Unistep Plus™ Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S061
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2022-11-28
- Decision code
- OK30
- Date received
- 2022-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New method for water bath sterilization.