PMA P920047S137

Device: Blazer™ II Cardiac Ablation System and Cable
Applicant: Boston Scientific Corp
PMA number: P920047
Supplement: S137
Product code: LPB
Decision date: 2025-08-14
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
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: Blazer™ II Cardiac Ablation System and Cable
Applicant: Boston Scientific Corp
PMA number: P920047
Supplement: S137
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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