PMA P980033S054
- Device
- Wallstent Venous Endoprosthesis with UNISTEP Plus
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S054
- Product code
- QKJ
- Decision date
- 2019-05-30
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- Add an alternate external Process Challenge Device (ePCD) to the 40°C sterilization cycle.
Current openFDA PMA Record#
- Device
- Wallstent Venous Endoprosthesis with UNISTEP Plus
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S054
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2019-05-30
- Decision code
- OK30
- Date received
- 2019-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate external Process Challenge Device (ePCD) to the 40°C sterilization cycle.