| 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. |
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| Device | INSPIRE II UPPER AIRWAY STIMULATOR |
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| Generic Name | Stimulator, hypoglossal nerve, implanted, apnea |
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| Applicant | Inspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369 |
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| PMA Number | P130008 |
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| Date Received | 05/01/2013 |
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| Decision Date | 04/30/2014 |
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| Product Code |
MNQ |
| Docket Number | 14M-0690 |
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| Notice Date | 05/29/2014 |
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| Advisory Committee |
Anesthesiology |
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| Clinical Trials | NCT01161420
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S009 S008 S003 S001 S005 S010 S011 S012 S013 S016 S017
S021 S022 S014 S004 S006 S002 S007 S023 S024 S025 S026 S018
S019 S020 S015 S032 S033 S038 S027 S028 S029 S056 S057 S058
S059 S060 S044 S050 S051 S035 S052 S053 S064 S088 S089 S075
S076 S079 S080 S081 S082 S083 S067 S068 S069 S098 S099 S100
S114 S115 S122 S124 S125 S126 S107 S034 S031 S045 S046 S054
S055 S061 S062 S041 S043 S036 S037 S039 S040 S047 S048 S049
S090 S092 S093 S096 S078 S103 S104 S105 S084 S085 S065 S066
S063 S071 S072 S077 S073 S074 S094 S095 S111 S112 S120 S121
S116 S117 S118 S119 S127 S129 S106 S113 S130 S131 S135 S137
S101 S102 S108 S109 S110 S097 S138 S139 S132 S133 |
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