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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 II Upper Airway Stimulator
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS
9700 63RD AVENUE NORTH
SUITE 200
MAPLE GROVE, MN 55369
PMA NumberP130008
Supplement NumberS021
Date Received03/29/2017
Decision Date06/23/2017
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to expand the Apnea Hypopnea Index (AHI) range from 20 to 65, to 15 to 65 events per hour.
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