PMA P240012
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- Product code
- SDL
- Decision date
- 2026-09-25
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Approval order statement
- Approval for changes to the temperature control components in the Neurostimulation Console and packaging changes for the Console.
Current openFDA PMA Record#
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S008
- Product code
- SDL
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Decision date
- 2026-09-25
- Decision code
- APPR
- Date received
- 2026-07-01
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the temperature control components in the Neurostimulation Console and packaging changes for the Console.