PMA P980033S066
- Device
- Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S066
- Product code
- QKJ
- Decision date
- 2024-06-27
- Classification
- Cardiovascular
- Generic name
- Stent, central venous
- Approval order statement
- a new automated cleaning system at your component supplier
Current openFDA PMA Record#
- Device
- Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S066
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2024-06-27
- Decision code
- OK30
- Date received
- 2024-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new automated cleaning system at your component supplier