PMA supplement
P170011 S039: Impella RP Flex with SmartAssist
FDA PMA supplement · Normal 180 Day Track · Abiomed, Inc.
Key facts
| Original PMA | P170011 |
|---|---|
| Supplement number | S039 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Impella RP Flex with SmartAssist |
| Generic name | Temporary non-roller type right heart support blood pump |
| Applicant | Abiomed, Inc. |
| Product code | PYX |
| Received date | Mar 31, 2022 |
| Decision date | Oct 28, 2022 |
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: