- Device
- WALLSTENT ENDOPROSTHESIS
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S055
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2019-07-25
- Decision code
- OK30
- Date received
- 2019-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the current software with new software to collect and process manufacturing test data, and track and trend capability data for various manufacturing areas.