PMA P130030S076

Device: REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire
Applicant: Boston Scientific Corp
PMA number: P130030
Supplement: S076
Product code: MAF
Decision date: 2023-07-27
Classification: Cardiovascular
Generic name: STENT, CORONARY
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: REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire
Applicant: Boston Scientific Corp
PMA number: P130030
Supplement: S076
Product code: MAF
Generic name: STENT, CORONARY
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