AeroPace® System
FDA premarket approval P240012/S001 · decided 2025-01-30
Approval details
- PMA number
- P240012
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AeroPace® System
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Applicant
- Lungpacer Medical USA, Inc.
- Date received
- 2024-12-31
- Decision date
- 2025-01-30
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- SDL
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Exton, PA
- Statement
- Approval of the protocol for the post-approval study AERO-PAS.
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