AeroPace® System
FDA premarket approval P240012 · decided 2024-12-04
Approval details
- PMA number
- P240012
- Trade name
- AeroPace® System
- Generic name
- Transvenous temporary phrenic nerve stimulator
- Applicant
- Lungpacer Medical USA, Inc.
- Date received
- 2024-04-08
- Decision date
- 2024-12-04
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- SDL
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Exton, PA
- Statement
- Approval for AeroPace® System. The AeroPace System is indicated to improve weaning success increase weaning, reduce ventilator days, and reduce reintubation - in patients ages 18 years or older on mechanical ventilation >= 96 hours and who have not weaned.
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