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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 NumberS003
Date Received08/20/2025
Decision Date09/29/2025
Product Code SDL 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software changes to the breath detection algorithm and baseline pressure calculation.
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