PMA P240012S001
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S001
- Product code
- SDL
- Decision date
- 2025-01-30
- Classification
- Anesthesiology
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Approval order statement
- Approval of the protocol for the post-approval study AERO-PAS.
Current openFDA PMA Record#
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S001
- Product code
- SDL
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Decision date
- 2025-01-30
- Decision code
- APPR
- Date received
- 2024-12-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study AERO-PAS.