Maestro 4000 Controller Firmware
FDA premarket approval P020025/S121 · decided 2019-08-23
Approval details
- PMA number
- P020025
- Supplement
- S121
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Maestro 4000 Controller Firmware
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2019-08-09
- Decision date
- 2019-08-23
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Update Maestro 4000 Controller FW from version 5.14 to version 5.23 (market approved) in the field.
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