PMA supplement
P060040 S005: THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P060040 |
|---|---|
| Supplement number | S005 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
| Generic name | Ventricular (assist) bypass |
| Applicant | ABBOTT MEDICAL |
| Product code | DSQ |
| Received date | Apr 20, 2009 |
| Decision date | Jan 20, 2010 |
| Docket number | 10M-0078 |
| Notice date | Feb 22, 2010 |
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: