PMA
P980012: NOVACOR LVAS
FDA PMA · Ventricular (assist) bypass · Worldheart, Inc.
Key facts
| PMA number | P980012 |
|---|---|
| Trade name | NOVACOR LVAS |
| Generic name | Ventricular (assist) bypass |
| Applicant | Worldheart, Inc. |
| Owner/operator | Digicom Electronics, Inc. |
| Product code | DSQ |
| Approval date | Sep 29, 1998 |
| Docket number | 99M-2605 |
| Establishment registration | 3006367638 |
| FEI number | 3006367638 |
At a glance
- 1–9 Supplements
- Jul 21, 2004 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: