- Device
- Blazer Prime HTD cardiac ablation catheter
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S127
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-06-04
- Decision code
- APPR
- Date received
- 2020-03-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the Control Wire Sleeve of the Blazer Prime HTD and Blazer Prime XP cardiac ablation catheters.