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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 NameMODEL 3024 INSPIRE II IMPLANTABLE PULSE GENERATOR (IPG)
Classification Namestimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS INC
PMA NumberP130008
Supplement NumberS007
Date Received03/25/2015
Decision Date04/22/2015
Product Code
MNQ[ Registered Establishments with MNQ ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an automated system for inspection of final sealed tray packages and a change in the supplier of gold preform components.
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