Inspire Upper Airway Stimulation System

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Premarket Approval P130008 S041

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a change in the method used to incorporate serial numbers inside the model 4063 lead’s is-1 connector boot.

DeviceInspire Upper Airway Stimulation System
Classification NameStimulator, Hypoglossal Nerve, Implanted, Apnea
Generic NameStimulator, Hypoglossal Nerve, Implanted, Apnea
ApplicantINSPIRE MEDICAL SYSTEMS
Date Received2019-04-23
Decision Date2019-07-22
PMAP130008
SupplementS041
Product CodeMNQ
Advisory CommitteeAnesthesiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address INSPIRE MEDICAL SYSTEMS 9700 63rd Avenue North suite 200 maple Grove, MN 55369

Supplemental Filings

Supplement NumberDateSupplement Type
P130008Original Filing
S093 2022-11-18 Normal 180 Day Track No User Fee
S092
S091
S090
S089
S088 2022-07-29 30-day Notice
S087
S086
S085
S084 2022-05-20 30-day Notice
S083 2022-03-15 30-day Notice
S082 2022-03-02 30-day Notice
S081 2022-02-17 30-day Notice
S080 2022-02-17 30-day Notice
S079 2022-02-11 30-day Notice
S078 2022-01-26 30-day Notice
S077 2022-01-05 30-day Notice
S076
S075 2021-10-07 30-day Notice
S074
S073 2021-08-13 Normal 180 Day Track No User Fee
S072
S071 2021-07-13 30-day Notice
S070
S069
S068
S067 2021-05-25 30-day Notice
S066 2021-05-14 30-day Notice
S065
S064 2021-03-12 30-day Notice
S063 2020-12-14 Normal 180 Day Track
S062 2020-09-14 30-day Notice
S061
S060 2020-08-31 30-day Notice
S059 2020-08-26 30-day Notice
S058 2020-08-20 30-day Notice
S057
S056
S055
S054 2020-06-25 30-day Notice
S053 2020-05-19 30-day Notice
S052 2020-05-14 Normal 180 Day Track No User Fee
S051 2020-01-31 30-day Notice
S050
S049 2019-12-17 Special (immediate Track)
S048 2019-12-12 30-day Notice
S047
S046 2019-08-16 30-day Notice
S045 2019-06-24 30-day Notice
S044 2019-05-23 30-day Notice
S043
S042
S041 2019-04-23 Real-time Process
S040 2019-01-29 30-day Notice
S039
S038 2018-12-11 30-day Notice
S037 2018-10-26 Real-time Process
S036 2018-10-15 30-day Notice
S035 2018-08-16 30-day Notice
S034 2018-04-16 Normal 180 Day Track
S033 2018-02-14 Real-time Process
S032 2018-02-05 30-day Notice
S031 2017-12-13 Normal 180 Day Track
S030
S029 2017-11-14 Normal 180 Day Track No User Fee
S028 2017-11-08 30-day Notice
S027 2017-10-13 30-day Notice
S026 2017-05-09 30-day Notice
S025 2017-05-08 30-day Notice
S024 2017-05-08 30-day Notice
S023 2017-05-04 Real-time Process
S022 2017-03-29 Normal 180 Day Track No User Fee
S021 2017-03-29 Normal 180 Day Track
S020 2017-01-23 Normal 180 Day Track
S019 2016-12-08 30-day Notice
S018 2016-11-23 30-day Notice
S017 2016-11-17 30-day Notice
S016 2016-10-06 Normal 180 Day Track
S015 2016-09-14 30-day Notice
S014 2016-07-05 30-day Notice
S013 2016-05-05 Normal 180 Day Track
S012 2016-04-22 30-day Notice
S011 2016-04-08 30-day Notice
S010 2016-03-30 Normal 180 Day Track No User Fee
S009 2015-11-12 Normal 180 Day Track
S008 2015-05-27 Real-time Process
S007 2015-03-25 30-day Notice
S006 2015-03-03 30-day Notice
S005 2015-01-28 30-day Notice
S004 2014-10-07 30-day Notice
S003 2014-07-23 Normal 180 Day Track No User Fee
S002 2014-06-30 Normal 180 Day Track
S001 2014-05-12 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00855728005017 P130008 001
00855728005055 P130008 001
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00855728005437 P130008 008
00855728005611 P130008 009
00855728005598 P130008 009
00855728005222 P130008 009
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10855728005458 P130008 031
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10855728005632 P130008 031
00855728005642 P130008 034
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00855728005826 P130008 034
10855728005656 P130008 037
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10810098650141 P130008 055
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00810098650007 P130008 068
00810098650151 P130008 068
00810098650083 P130008 069
00855728005925 P130008 069
00855728005796 P130008 074
00855728005949 P130008 074
00810098650212 P130008 101

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