PMA supplement
P870072 S005: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
FDA PMA supplement · Panel Track · Thoratec Laboratories Corp.
Key facts
| Original PMA | P870072 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM |
| Generic name | Ventricular (assist) bypass |
| Applicant | Thoratec Laboratories Corp. |
| Product code | DSQ |
| Received date | Oct 6, 1997 |
| Decision date | May 21, 1998 |
| Docket number | 99M-1521 |
| Notice date | Jun 9, 1999 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: