PMA P980033S049
- Device
- Wallstent (Venous) Endoprosthesis with unistep plus delivery system
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S049
- Product code
- QKJ
- Decision date
- 2017-07-03
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- Alternate vendor for stainless steel tubing for use in the delivery system.
Current openFDA PMA Record#
- Device
- Wallstent (Venous) Endoprosthesis with unistep plus delivery system
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S049
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2017-07-03
- Decision code
- OK30
- Date received
- 2017-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate vendor for stainless steel tubing for use in the delivery system.