- Device
- Blazer Open-Irrigated Ablation Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S073
- 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.