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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
PMA NumberP130008
Supplement NumberS004
Date Received10/07/2014
Decision Date11/06/2014
Product Code
MNQ[ Registered Establishments with MNQ ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Install a new cure and preheat oven at the contract manufacturer¿s medtronic puerto rico operations company (mproc) location.
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