PMA P980033S052
- Device
- Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S052
- Product code
- QKJ
- Decision date
- 2018-12-17
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- Modify the cleaning technique used for a packaging tray configuration.
Current openFDA PMA Record#
- Device
- Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S052
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2018-12-17
- Decision code
- OK30
- Date received
- 2018-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the cleaning technique used for a packaging tray configuration.