- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S126
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-05-19
- Decision code
- APPR
- Date received
- 2020-03-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.