Maestro 4000 Controller
FDA premarket approval P020025/S113 · decided 2019-01-28
Approval details
- PMA number
- P020025
- Supplement
- S113
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Maestro 4000 Controller
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2018-06-21
- Decision date
- 2019-01-28
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval to update the firmware/software of the Maestro 4000 Controller from version 5.14 to version 5.23 and the MetriQ Pump version 0.0.64 to version 1.1.
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