PMA supplement
P100047 S135: HeartWare Ventricular Assist System (HVAD)
FDA PMA supplement · Special (Immediate Track) · Medtronic
Key facts
| Original PMA | P100047 |
|---|---|
| Supplement number | S135 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HeartWare Ventricular Assist System (HVAD) |
| Generic name | Ventricular (assist) bypass |
| Applicant | Medtronic |
| Product code | DSQ |
| Received date | Feb 19, 2019 |
| Decision date | Mar 13, 2019 |
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: