PMA supplement
P170011 S061: Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System
FDA PMA supplement · Real-Time Process · Abiomed, Inc.
Key facts
| Original PMA | P170011 |
|---|---|
| Supplement number | S061 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System |
| Generic name | Temporary non-roller type right heart support blood pump |
| Applicant | Abiomed, Inc. |
| Product code | PYX |
| Received date | Oct 23, 2025 |
| Decision date | Feb 6, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: