PMA
P100047: HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA PMA · Ventricular (assist) bypass · Medtronic
Key facts
| PMA number | P100047 |
|---|---|
| Trade name | HEARTWARE VENTRICULAR ASSIST SYSTEM |
| Generic name | Ventricular (assist) bypass |
| Applicant | Medtronic |
| Owner/operator | Medtronic, Inc. |
| Product code | DSQ |
| Approval date | Nov 20, 2012 |
| Docket number | 12M-1184 |
| Notice date | Dec 5, 2012 |
| Establishment registration | 3001504994 |
| FEI number | 3001504994 |
At a glance
- 100–999 Supplements
- Sep 23, 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- No Withdrawn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: