Data / Medical devices / United States / Lungpacer Medical Usa, Inc.
Lungpacer Medical Usa, Inc.: FDA-registered device maker in Exton, PA, United States, 1 PMA approval
Lungpacer Medical Usa, Inc. is registered with the FDA (registration 3014139597) in Exton, PA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated December 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014139597
- Address
- 260 Sierra Dr Ste 116, Exton, PA, United States, 19341
- Owner or operator
- Lungpacer Medical USA, Inc. (10092127)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 6, 2024
- Registered through
- 2026
- Brand names listed
- AeroPace System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transvenous Temporary Phrenic Nerve Stimulator | SDL | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 4, 2024 | P240012 | AeroPace® System | SDL | 8 | September 25, 2026 | accessdata.fda.gov |
Updated September 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.