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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, hypoglossal nerve, implanted, apnea
Generic Namestimulator, hypoglossal nerve, implanted, apnea
9700 63rd avenue north
suite 200
maple grove, MN 55369
PMA NumberP130008
Date Received05/01/2013
Decision Date04/30/2014
Product Code
MNQ[ Registered Establishments with MNQ ]
Docket Number 14M-0690
Notice Date 05/29/2014
Advisory Committee Anesthesiology
Clinical Trials NCT01161420
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the inspire upper airway stimulation (uas) system, which includes the model 3024 implantable pulse generator, the model 4063 stimulation lead, the model 4323 sensing lead, the model 2740physician programmer, and the model 3032 patient programmer. The device is used to treat a subset of patients with moderate to severe obstructive sleep apnea (osa) (apnea-hypopnea index [ahi] of greater or equal to 20 and less than or equal to 65). Inspire uas is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (pap) treatments (such as continuous positive airway pressure [cpap] or bilevel positive airway pressure [bpap] machines) and who do not have a complete concentric collapse at the soft palate level. Pap failure is defined as an inability to eliminate osa (ahi of greater than 20 despite pap usage) and pap intolerance is defined as: 1) inability to use pap (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use pap (for example, a patient returns the pap system after attempting to use it).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S014 S015