- Device
- IntellaNav MiFi XP amd IntellaNav XP
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S123
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-01-27
- Decision code
- APPR
- Date received
- 2019-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and associated manufacturing changes to the magnetic tracking sensor found in IntellaNav catheter families.