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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.
 
DeviceMODEL 4323 PRESSURE SENSING LEAD ADAPTER COMPONENT
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS
9700 63RD AVENUE NORTH
SUITE 200
MAPLE GROVE, MN 55369
PMA NumberP130008
Supplement NumberS019
Date Received12/08/2016
Decision Date01/06/2017
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  
Supplier change for the lead adapter component used in the Model 4323 Pressure Sensing Lead.
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