PMA supplement
P030011 S097: SynCardia Total Artificial Heart (STAH) System
FDA PMA supplement · Real-Time Process · Syncardia Systems, LLC
Key facts
| Original PMA | P030011 |
|---|---|
| Supplement number | S097 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SynCardia Total Artificial Heart (STAH) System |
| Generic name | Artificial heart |
| Applicant | Syncardia Systems, LLC |
| Product code | LOZ |
| Received date | Oct 31, 2025 |
| Decision date | Feb 20, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: