PMA P240012S002
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S002
- Product code
- SDL
- Decision date
- 2025-09-23
- Classification
- Anesthesiology
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Approval order statement
- Approval of catheter manifold changes, flex circuit changes, and addition of dilator size.
Current openFDA PMA Record#
- Device
- AeroPace® System
- Applicant
- Lungpacer Medical USA, Inc.
- PMA number
- P240012
- Supplement
- S002
- Product code
- SDL
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Decision date
- 2025-09-23
- Decision code
- APPR
- Date received
- 2025-06-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of catheter manifold changes, flex circuit changes, and addition of dilator size.