PMA P130030S069
- Device
- REBEL Platinum Chromium Coronary Stent System Monorail and Over-the-Wire
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S069
- Product code
- MAF
- Decision date
- 2020-07-01
- Generic name
- STENT, CORONARY
- Approval order statement
- Increase to the barrel extrusion temperature used during the manufacturing of the balloon tube.
Current openFDA PMA Record#
- Device
- REBEL Platinum Chromium Coronary Stent System Monorail and Over-the-Wire
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Supplement
- S069
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2020-07-01
- Decision code
- OK30
- Date received
- 2020-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase to the barrel extrusion temperature used during the manufacturing of the balloon tube.