AeroPace® System
FDA premarket approval P240012/S002 · decided 2025-09-23
Approval details
- PMA number
- P240012
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AeroPace® System
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Applicant
- Lungpacer Medical USA, Inc.
- Date received
- 2025-06-25
- Decision date
- 2025-09-23
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- SDL
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Exton, PA
- Statement
- Approval of catheter manifold changes, flex circuit changes, and addition of dilator size.
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