PMA
P160054: HeartMate 3™ Left Ventricular Assist System
FDA PMA · Ventricular (assist) bypass · ABBOTT MEDICAL
Key facts
| PMA number | P160054 |
|---|---|
| Trade name | HeartMate 3™ Left Ventricular Assist System |
| Generic name | Ventricular (assist) bypass |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DSQ |
| Approval date | Aug 23, 2017 |
| Docket number | 17M-5320 |
| Notice date | Sep 1, 2017 |
| Establishment registration | 2916596 |
| FEI number | 2916596 |
At a glance
- 100–999 Supplements
- Oct 1, 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- No Withdrawn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: