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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINSPIRE II UPPER AIRWAY STIMULATOR
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantINSPIRE MEDICAL SYSTEMS
9700 63RD AVENUE NORTH
SUITE 200
MAPLE GROVE, MN 55369
PMA NumberP130008
Date Received05/01/2013
Decision Date04/30/2014
Product Code MNQ 
Docket Number 14M-0690
Notice Date 05/29/2014
Advisory Committee Anesthesiology
Clinical TrialsNCT01161420
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S103 S104 S105  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 S031 S032 S033 
S034 S035 S036 S037 S038 S039 S040 S041 S043 S044 S045 S046 
S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S071 
S072 S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 
S084 S085 S088 S089 S090 S092 S093 S094 S095 S096 S097 S099 
S100 S101 S102 S106 S107 S108 S109 S110 
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