PMA P150005S039
- Device
- MetriQ Pump
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S039
- Product code
- OAD
- Decision date
- 2019-01-28
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order 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.
Current openFDA PMA Record#
- Device
- MetriQ Pump
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S039
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-01-28
- Decision code
- APPR
- Date received
- 2018-06-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.