PMA P980033S025
- Device
- WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S025
- Product code
- QKJ
- Decision date
- 2012-10-24
- Classification
- Stent, Coronary
- Generic name
- Stent, central venous
- Approval order statement
- CHANGE TO THE AERATION CYCLE TIME FOR AN ETHYLENE OXIDE STERILIZATION CYCLE.
Current openFDA PMA Record#
- Device
- WALLSTENT VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P980033
- Supplement
- S025
- Product code
- QKJ
- Generic name
- Stent, central venous
- Decision date
- 2012-10-24
- Decision code
- OK30
- Date received
- 2012-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE AERATION CYCLE TIME FOR AN ETHYLENE OXIDE STERILIZATION CYCLE.