- Device
- Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S043
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-05-29
- Decision code
- APPR
- Date received
- 2019-03-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and labeling changes for the Maestro Ablation Connection Box (ACB) to be compliant with IEC 60601-1-2:2014.