Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: AeroPace® System
• Generic Name: Transvenous temporary phrenic nerve stimulator
• Applicant: Lungpacer Medical USA, Inc.; 260 Sierra Dr.; Suite 116; Exton, PA 19341
• PMA Number: P240012
• Date Received: 04/08/2024
• Decision Date: 12/04/2024
• Product Code: SDL
• Advisory Committee: Anesthesiology
• Clinical Trials: NCT03783884
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order 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.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007