PMA
P870072: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
FDA PMA · Ventricular (assist) bypass · Thoratec Laboratories Corp.
Key facts
| PMA number | P870072 |
|---|---|
| Trade name | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM |
| Generic name | Ventricular (assist) bypass |
| Applicant | Thoratec Laboratories Corp. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | DSQ |
| Approval date | Dec 20, 1995 |
| Docket number | 97M-0136 |
| Notice date | Apr 11, 1997 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Jun 14, 2016 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- Yes Withdrawn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: