- Device
- IntellaNav MiFi Open-Irrigated Ablation Catheters, IntellaTip MiFi Open-Irrigated Ablation Catheters, IntellaNav Open-Ir
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S064
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-07-20
- Decision code
- OK30
- Date received
- 2021-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Tightened acceptance criterion and a duplicated test method to address reports of electrical malfunctions.