PMA
P920014: HEARTMATE VE LVAS
FDA PMA · Ventricular (assist) bypass · Thoratec Corp
Key facts
| PMA number | P920014 |
|---|---|
| Trade name | HEARTMATE VE LVAS |
| Generic name | Ventricular (assist) bypass |
| Applicant | Thoratec Corp |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DSQ |
| Approval date | Sep 30, 1994 |
| Docket number | 94M-0404 |
| Notice date | Oct 3, 1996 |
| Establishment registration | 2916596 |
| FEI number | 2916596 |
At a glance
- 10–99 Supplements
- Dec 21, 2011 Latest supplement decision
- Yes Withdrawn
- No 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: