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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAeroPace® System
Generic NameTransvenous temporary phrenic nerve stimulator
ApplicantLungpacer Medical USA, Inc.
260 Sierra Dr.
Suite 116
Exton, PA 19341
PMA NumberP240012
Supplement NumberS007
Date Received05/26/2026
Decision Date06/22/2026
Product Code SDL 
Advisory Committee Anesthesiology
Clinical TrialsNCT03783884
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240012
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