PMA P020025S146

Device: Blazer™ II XP Cardiac Ablation Catheter and Cable
Applicant: Boston Scientific
PMA number: P020025
Supplement: S146
Product code: OAD
Decision date: 2025-08-14
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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 XP Cardiac Ablation Catheter and Cable
Applicant: Boston Scientific
PMA number: P020025
Supplement: S146
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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