- Device
- Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S086
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2024-11-14
- Decision code
- APPR
- Date received
- 2024-08-16
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change in the adhesive used in the proximal extension tube to female luer lock adhesive joint, a new product specification, and modifications to manufacturing processes