- Device
- Open-Irrigated Cardiac Ablation Catheters
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S072
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2022-11-21
- Decision code
- APPR
- Date received
- 2022-08-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for supplier and design changes to the Female Luer Lock Adaptor component on Open Irrigated Cardiac Ablation Catheters.