PMA supplement
P240012 S001: AeroPace® System
FDA PMA supplement · Normal 180 Day Track No User Fee · Lungpacer Medical USA, Inc.
Key facts
| Original PMA | P240012 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | AeroPace® System |
| Generic name | Transvenous temporary phrenic nerve stimulator |
| Applicant | Lungpacer Medical USA, Inc. |
| Product code | SDL |
| Received date | Dec 31, 2024 |
| Decision date | Jan 30, 2025 |
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: