PMA P980033S023
- Device
- WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S023
- Product code
- QKJ
- Decision date
- 2012-09-06
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
Current openFDA PMA Record#
- Device
- WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S023
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2012-09-06
- Decision code
- OK30
- Date received
- 2012-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.