PMA
P900023: ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM
FDA PMA · Ventricular (assist) bypass · Abiomed Cardiovascular, Inc.
Key facts
| PMA number | P900023 |
|---|---|
| Trade name | ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM |
| Generic name | Ventricular (assist) bypass |
| Applicant | Abiomed Cardiovascular, Inc. |
| Owner/operator | ABIOMED, INC. |
| Product code | DSQ |
| Approval date | Nov 20, 1992 |
| Docket number | 92M-0477 |
| Notice date | Jul 2, 1993 |
| Establishment registration | 1220648 |
| FEI number | 1220648 |
At a glance
- 10–99 Supplements
- Jun 26, 2012 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- Yes Withdrawn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: