PMA supplement
P140003 S080: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist
FDA PMA supplement · Normal 180 Day Track · Abiomed, Inc.
Key facts
| Original PMA | P140003 |
|---|---|
| Supplement number | S080 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist |
| Generic name | Temporary non-roller type left heart support blood pump |
| Applicant | Abiomed, Inc. |
| Product code | OZD |
| Received date | Mar 31, 2021 |
| Decision date | Jun 28, 2021 |
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: