PMA
P030011: SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
FDA PMA · Artificial heart · Syncardia Systems, LLC
Key facts
| PMA number | P030011 |
|---|---|
| Trade name | SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) |
| Generic name | Artificial heart |
| Applicant | Syncardia Systems, LLC |
| Owner/operator | SYNCARDIA SYSTEMS, LLC |
| Product code | LOZ |
| Approval date | Oct 15, 2004 |
| Docket number | 04M-0471 |
| Notice date | Oct 27, 2004 |
| Establishment registration | 3003761017 |
| FEI number | 3003761017 |
At a glance
- 10–99 Supplements
- Jul 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: