PMA supplement
P140003 S056: Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems
FDA PMA supplement · Special (Immediate Track) · Abiomed, Inc.
Key facts
| Original PMA | P140003 |
|---|---|
| Supplement number | S056 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems |
| Generic name | Temporary non-roller type left heart support blood pump |
| Applicant | Abiomed, Inc. |
| Product code | OZD |
| Received date | Aug 26, 2019 |
| Decision date | Sep 24, 2019 |
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: