| 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: |
S031 S027 S032 S033 S034 S036 S045 S046 S047 S048 S049 S050
S041 S063 S055 S056 S052 S053 S005 S057 S058 S059 S060
S051 S038 S039 S040 S090 S092 S093 S075 S076 S084 S098 S099
S100 S126 S127 S114 S115 S104 S105 S135 S137 S138 S017 S018
S019 S021 S022 S010 S011 S012 S013 S014 S023 S024 S025 S026
S016 S028 S029 S035 S061 S062 S043 S044 S037 S054 S083 S094
S095 S064 S065 S071 S072 S073 S074 S097 S111 S112 S120 S107
S129 S101 S102 S103 S003 S001 S008 S085 S088 S077 S078 S066
S067 S068 S069 S089 S004 S006 S002 S007 S096 S079 S080 S081
S082 S015 S020 S121 S122 S124 S125 S130 S131 S116 S117 S118
S119 S106 S113 S132 S133 S108 S109 S110 S009 |
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