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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 Implantable Pulse Generator (IPG)
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS
9700 63RD AVENUE NORTH
SUITE 200
MAPLE GROVE, MN 55369
PMA NumberP130008
Supplement NumberS088
Date Received07/29/2022
Decision Date08/19/2022
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Additional qualified supplier for barium titanate.
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