PMA P130030S074
- Device
- REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S074
- Product code
- MAF
- Decision date
- 2022-11-15
- Generic name
- STENT, CORONARY
- Approval order statement
- Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.
Current openFDA PMA Record#
- Device
- REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S074
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2022-11-15
- Decision code
- OK30
- Date received
- 2022-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.