PMA P020025S121
- Device
- Maestro 4000 Controller Firmware
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S121
- Product code
- OAD
- Decision date
- 2019-08-23
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Update Maestro 4000 Controller FW from version 5.14 to version 5.23 (market approved) in the field.
Current openFDA PMA Record#
- Device
- Maestro 4000 Controller Firmware
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S121
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-08-23
- Decision code
- OK30
- Date received
- 2019-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update Maestro 4000 Controller FW from version 5.14 to version 5.23 (market approved) in the field.