PMA supplement
P140003 S116: Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist
FDA PMA supplement · Special (Immediate Track) · Abiomed, Inc.
Key facts
| Original PMA | P140003 |
|---|---|
| Supplement number | S116 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist |
| Generic name | Temporary non-roller type left heart support blood pump |
| Applicant | Abiomed, Inc. |
| Product code | OZD |
| Received date | Dec 8, 2023 |
| Decision date | Jan 5, 2024 |
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: