PMA P130030
- 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
- 2026-03-10
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR THE REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH DE NOVO LESIONS <= 28 MM IN LENGTH IN NATIVE CORONARY ARTERIES WITH A REFERENCE VESSEL DIAMETER (RVD) OF >= 2.25 TO >= 4.50 MM.
Current openFDA PMA Record#
- Device
- REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE
- Applicant
- Boston Scientific Corp
- PMA number
- P130030
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2026-03-10
- Decision code
- APPR
- Date received
- 2013-12-30
- Approval order statement
- APPROVAL FOR THE REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH DE NOVO LESIONS = 2.25 TO >= 4.50 MM.