PMA supplement
P920014 S016: THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)
FDA PMA supplement · Panel Track · Thoratec Corp
Key facts
| Original PMA | P920014 |
|---|---|
| Supplement number | S016 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) |
| Generic name | Ventricular (assist) bypass |
| Applicant | Thoratec Corp |
| Product code | DSQ |
| Received date | Oct 16, 2001 |
| Decision date | Nov 6, 2002 |
At a glance
- Yes Expedited review granted
- Yes 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: