Maestro Ablation Connection Box, IntellaNav OI
FDA premarket approval P020025/S118 · decided 2019-05-29
Approval details
- PMA number
- P020025
- Supplement
- S118
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Maestro Ablation Connection Box, IntellaNav OI
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2019-03-22
- Decision date
- 2019-05-29
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval to the design and labeling changes for the Maestro Ablation Connection Box (ACB) to be compliant with IEC 60601-1-2:2014.
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