# Syncardia Systems, LLC

- Location (FDA's records): Tucson
- FDA decisions: 1 (2004–2004): 1 original PMA approval
- Product codes: LOZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 5 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P030011: Syncardia Temporary Cardio West Total Artificial Heart (Tah-T) (Oct 15, 2004)

Source page: https://510kreport.com/company/syncardia-systems