PMA P020025S137

Device: Blazer II XP Cardiac Ablation Catheter and Cable
Applicant: Boston Scientific
PMA number: P020025
Supplement: S137
Product code: OAD
Decision date: 2022-11-15
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.

Current openFDA PMA Record#

Device: Blazer II XP Cardiac Ablation Catheter and Cable
Applicant: Boston Scientific
PMA number: P020025
Supplement: S137
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2022-11-15
Decision code: OK30
Date received: 2022-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.