- Device
- IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S132
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-08-17
- Decision code
- APPR
- Date received
- 2021-05-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling, including modified warnings and directions for use.