PMA P900056S221

Device: ROTABLATOR™ Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S221
Product code: MCX
Decision date: 2025-08-14
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: for a manufacturing site located at Boston Scientific de Costa Rica, S.R.L., El Coyol Alajuela, Coyol, Costa Rica (FEI: 3007695959) to perform ethylene oxide sterilization activities

Current openFDA PMA Record#

Device: ROTABLATOR™ Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S221
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2025-08-14
Decision code: APPR
Date received: 2025-07-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for a manufacturing site located at Boston Scientific de Costa Rica, S.R.L., El Coyol Alajuela, Coyol, Costa Rica (FEI: 3007695959) to perform ethylene oxide sterilization activities