PMA P240012S004
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S004
- Product code
- SDL
- Decision date
- 2026-01-14
- Classification
- Anesthesiology
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Approval order statement
- Addition of two suppliers of PCBAs included in the assembly of the Neurostimulation Console and Handheld Controller.
Current openFDA PMA Record#
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S004
- Product code
- SDL
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Decision date
- 2026-01-14
- Decision code
- OK30
- Date received
- 2025-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two suppliers of PCBAs included in the assembly of the Neurostimulation Console and Handheld Controller.