PMA supplement
P160054 S094: HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System
FDA PMA supplement · 135 Review Track For 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P160054 |
|---|---|
| Supplement number | S094 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System |
| Generic name | Ventricular (assist) bypass |
| Applicant | ABBOTT MEDICAL |
| Product code | DSQ |
| Received date | Jan 15, 2025 |
| Decision date | Oct 17, 2025 |
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: