PMA P240012S006
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S006
- Product code
- SDL
- Decision date
- 2026-06-22
- Classification
- Anesthesiology
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Approval order statement
- Approval for dimensional changes to the luer connectors of the Neurostimulation Catheter.
Current openFDA PMA Record#
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S006
- Product code
- SDL
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Decision date
- 2026-06-22
- Decision code
- APPR
- Date received
- 2026-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for dimensional changes to the luer connectors of the Neurostimulation Catheter.