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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 Upper Airway Stimulation (UAS) System, Model 3028 IPG
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS
9700 63RD AVENUE NORTH
SUITE 200
MAPLE GROVE, MN 55369
PMA NumberP130008
Supplement NumberS016
Date Received10/06/2016
Decision Date05/05/2017
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Model 3028 MR Conditional Implantable Pulse Generator (IPG).
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