PMA P980033S051
- Device
- Wallstent (Venous) Endoprosthesis with Unisteo Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S051
- Product code
- QKJ
- Decision date
- 2018-12-21
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- Sampling plan modification and manufacturing equipment alternative for a device component.
Current openFDA PMA Record#
- Device
- Wallstent (Venous) Endoprosthesis with Unisteo Plus Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S051
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2018-12-21
- Decision code
- OK30
- Date received
- 2018-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sampling plan modification and manufacturing equipment alternative for a device component.