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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINSPIRE II UPPER AIRWAY STIMULATOR
Classification Namestimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS
PMA NumberP130008
Supplement NumberS002
Date Received06/30/2014
Decision Date02/05/2015
Product Code
MNQ[ Registered Establishments with MNQ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the tablet hardware and operating system of the model 2740 physician programmer, and related changes to the model 2740 programmer manual.
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