- Device
- IntellaNav Open Irrigated Ablation Catheters, IntellaNav MiFi Open-Irrigated Ablation Catheters
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S067
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-09-07
- Decision code
- OK30
- Date received
- 2021-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an inspection for an electrical component located inside the handle of IntellaNav catheters.