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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.
 
DeviceInspire Model 3028 Implantable Pulse Generator (IPG)
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS107
Date Received02/13/2024
Decision Date03/13/2024
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The change associated with this submission is to remove the time-bounded 72 hours testing window between burn in and functional test. If the units exceed 96 hours (24 hours cool down + 72 hours in scope of this submission) after burn-in, the units need to complete an additional 24-hour burn-in and 24-hour cooldown prior to functional test.
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