PMA
P240012: AeroPace® System
FDA PMA · Transvenous temporary phrenic nerve stimulator · Lungpacer Medical USA, Inc.
Key facts
| PMA number | P240012 |
|---|---|
| Trade name | AeroPace® System |
| Generic name | Transvenous temporary phrenic nerve stimulator |
| Applicant | Lungpacer Medical USA, Inc. |
| Owner/operator | Lungpacer Medical USA, Inc. |
| Product code | SDL |
| Approval date | Dec 4, 2024 |
| Establishment registration | 3014139597 |
| FEI number | 3014139597 |
At a glance
- 1–9 Supplements
- Sep 25, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: