PMA
P170011: Impella RP System
FDA PMA · Temporary non-roller type right heart support blood pump · Abiomed, Inc.
Key facts
| PMA number | P170011 |
|---|---|
| Trade name | Impella RP System |
| Generic name | Temporary non-roller type right heart support blood pump |
| Applicant | Abiomed, Inc. |
| Owner/operator | ABIOMED, INC. |
| Product code | PYX |
| Approval date | Sep 20, 2017 |
| Docket number | 17M-5884 |
| Notice date | Sep 22, 2017 |
| Establishment registration | 1220648 |
| FEI number | 1220648 |
At a glance
- 10–99 Supplements
- Apr 1, 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- No Withdrawn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: