PMA P130030S077

Device: REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire
Applicant: Boston Scientific Corp
PMA number: P130030
Supplement: S077
Product code: MAF
Decision date: 2023-12-12
Classification: Cardiovascular
Generic name: STENT, CORONARY
Approval order statement: changes to the sterilization Chamber 9 Programmable Logic Controller 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: S077
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2023-12-12
Decision code: OK30
Date received: 2023-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility