PMA
P140003: IMPELLA 2.5 System
FDA PMA · Temporary non-roller type left heart support blood pump · Abiomed, Inc.
Key facts
| PMA number | P140003 |
|---|---|
| Trade name | IMPELLA 2.5 System |
| Generic name | Temporary non-roller type left heart support blood pump |
| Applicant | Abiomed, Inc. |
| Owner/operator | ABIOMED, INC. |
| Product code | OZD |
| Approval date | Mar 23, 2015 |
| Docket number | 25M-1177 |
| Notice date | Apr 10, 2015 |
| Establishment registration | 1220648 |
| FEI number | 1220648 |
At a glance
- 100–999 Supplements
- Jun 15, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: