PMA P030011S084
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S084
- Product code
- LOZ
- Decision date
- 2023-04-12
- Classification
- Cardiovascular
- Generic name
- Artificial heart
- Approval order statement
- Approval for a software change to the cardiac output and fill volume calculations of the Freedom Driver.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S084
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2023-04-12
- Decision code
- APPR
- Date received
- 2023-02-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software change to the cardiac output and fill volume calculations of the Freedom Driver.