- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S080
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2022-11-22
- Decision code
- APPR
- Date received
- 2022-06-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for alternate Companion 2 battery printed circuit board assembly (PCBA) sub-components and a new mold for a component of the battery assembly.