PMA P060006S107
- Device
- Express® SD Renal Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S107
- Product code
- NIN
- Decision date
- 2023-07-27
- Classification
- Cardiovascular
- Generic name
- STENT, RENAL
- Approval order statement
- Change to the PLC software/control system for a sterilization chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility
Current openFDA PMA Record#
- Device
- Express® SD Renal Monorail Premounted Stent System
- Applicant
- Boston Scientific Corp
- PMA number
- P060006
- Supplement
- S107
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2023-07-27
- Decision code
- OK30
- Date received
- 2023-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the PLC software/control system for a sterilization chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility