PMA P980033S058
- Device
- Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S058
- Product code
- QKJ
- Decision date
- 2020-07-22
- Generic name
- Stent, central venous
- Approval order statement
- Change in the sampling plan for an extrusion process.
Current openFDA PMA Record#
- Device
- Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S058
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2020-07-22
- Decision code
- OK30
- Date received
- 2020-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the sampling plan for an extrusion process.