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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 NumberS008
Date Received07/01/2026
Decision Date09/25/2026
Product Code SDL 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the temperature control components in the Neurostimulation Console and packaging changes for the Console.
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