Inspire Medical Systems

FDA Filings

This page includes the latest FDA filings for Inspire Medical Systems. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P130008S078 INSPIRE MEDICAL SYSTEMS	Inspire Implantable Pulse Generator (IPG) Model 2580 Patient Remote	2022-02-11
PMA P130008S077 INSPIRE MEDICAL SYSTEMS	Inspire Implantable Pulse Generator (IPG)	2022-02-02
PMA P130008S075 INSPIRE MEDICAL SYSTEMS	Inspire Model 4340 Respiratory Sensing Lead	2021-11-03
PMA P130008S073 INSPIRE MEDICAL SYSTEMS	Inspire II Upper Airway Stimulator	2021-09-10
PMA P130008S071 INSPIRE MEDICAL SYSTEMS	Inspire Implantable Pulse Generator (IPG)	2021-08-12
PMA P130008S067 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation (UAS)	2021-06-24
PMA P130008S066 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation (UAS)	2021-06-11
PMA P130008S064 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation System	2021-04-09
PMA P130008S063 INSPIRE MEDICAL SYSTEMS	Inspire II Upper Airway Stimulator	2021-03-12
PMA P130008S062 INSPIRE MEDICAL SYSTEMS	Inspire IV IPG	2020-10-14
PMA P130008S060 INSPIRE MEDICAL SYSTEMS	Inspire IV IPG	2020-09-29
PMA P130008S059 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation	2020-09-24
PMA P130008S058 INSPIRE MEDICAL SYSTEMS	Inspire Implantable Pulse Generator	2020-09-16
PMA P130008S054 INSPIRE MEDICAL SYSTEMS	Inspire Respiratory Sensing Lead	2020-07-20
PMA P130008S053 INSPIRE MEDICAL SYSTEMS	Inspire IV IPG	2020-06-18
PMA P130008S052 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation	2020-06-12
PMA P130008S051 INSPIRE MEDICAL SYSTEMS	Inspire II Upper Airway Stimulator	2020-03-02
PMA P130008S049 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation System	2020-01-16
PMA P130008S048 INSPIRE MEDICAL SYSTEMS	Implantable Pulse Generator, Sensing Lead, and Stimulation Lead	2020-01-10
PMA P130008S046 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation System	2019-09-11
PMA P130008S045 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation System	2019-07-25
PMA P130008S041 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation System	2019-07-22
PMA P130008S044 INSPIRE MEDICAL SYSTEMS	Inspire II Upper Airway Stimulator	2019-06-21
PMA P130008S040 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulator	2019-03-06
PMA P130008S031 INSPIRE MEDICAL SYSTEMS	Model 4340 Respiratory Sensing Lead	2019-01-28
PMA P130008S037 INSPIRE MEDICAL SYSTEMS	Model 3028 Implantable Pulse Generator	2019-01-24
PMA P130008S038 INSPIRE MEDICAL SYSTEMS	Stimulator, Hypoglossal Nerve, Implanted, Apnea	2019-01-09
PMA P130008S036 INSPIRE MEDICAL SYSTEMS	Inspire Model 4323 Sensing Lead	2018-11-19
PMA P130008S034 INSPIRE MEDICAL SYSTEMS	Inspire Model 2740 Physician Programmer	2018-11-01
PMA P130008S035 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2018-09-14
PMA P130008S033 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulator	2018-05-15
PMA P130008S029 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation Therapy	2018-05-11
PMA P130008S032 INSPIRE MEDICAL SYSTEMS	Pressure Sensor Test Limits	2018-03-07
PMA P130008S028 INSPIRE MEDICAL SYSTEMS	Inspire IV IPG	2017-12-08
PMA P130008S027 INSPIRE MEDICAL SYSTEMS	Inspire IV IPG	2017-11-08
PMA P130008S022 INSPIRE MEDICAL SYSTEMS	Inspire II Upper Airway Stimulator	2017-09-11
PMA P130008S020 INSPIRE MEDICAL SYSTEMS	MODEL 2740 INSPIRE PROGRAMMER SYSTEM	2017-08-02
PMA P130008S023 INSPIRE MEDICAL SYSTEMS	Sensing Lead	2017-07-28
PMA P130008S021 INSPIRE MEDICAL SYSTEMS	Inspire II Upper Airway Stimulator	2017-06-23
PMA P130008S026 INSPIRE MEDICAL SYSTEMS	Inspire Medical System Model 3028 Hybrid Process	2017-06-09
PMA P130008S025 INSPIRE MEDICAL SYSTEMS	Model 3028 IPG	2017-06-07
PMA P130008S024 INSPIRE MEDICAL SYSTEMS	Inspire Medical Systems Model 3028 Implantable Pulse Generator	2017-06-07
PMA P130008S016 INSPIRE MEDICAL SYSTEMS	Inspire Upper Airway Stimulation (UAS) System, Model 3028 IPG	2017-05-05
PMA P130008S019 INSPIRE MEDICAL SYSTEMS	MODEL 4323 PRESSURE SENSING LEAD ADAPTER COMPONENT	2017-01-06
PMA P130008S018 INSPIRE MEDICAL SYSTEMS	Pressure Sensing Lead	2016-12-22
PMA P130008S017 INSPIRE MEDICAL SYSTEMS	Inspire II Implantable Pulse Generator	2016-12-16
PMA P130008S013 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2016-12-05
PMA P130008S015 INSPIRE MEDICAL SYSTEMS	INSPIRE II IMPLANTABLE PULSE GENERATOR	2016-10-14
PMA P130008S014 INSPIRE MEDICAL SYSTEMS	INSPIRE II IMPLANTABLE PULSE GENERATOR	2016-08-03
PMA P130008S009 INSPIRE MEDICAL SYSTEMS	INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM	2016-06-02
PMA P130008S010 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATION SYSTEM	2016-06-01
PMA P130008S012 INSPIRE MEDICAL SYSTEMS	INSPIRE PROGRAMMER SYSTEM	2016-05-20
PMA P130008S011 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2016-05-16
PMA P130008S008 INSPIRE MEDICAL SYSTEMS	INSPIRE UPPER AIRWAY STIMULATION THERAPY	2015-08-24
PMA P130008S007 INSPIRE MEDICAL SYSTEMS	MODEL 3024 INSPIRE II IMPLANTABLE PULSE GENERATOR (IPG)	2015-04-22
PMA P130008S006 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2015-04-02
PMA P130008S005 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2015-02-27
PMA P130008S002 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2015-02-05
PMA P130008S004 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2014-11-06
PMA P130008S003 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2014-09-19
PMA P130008S001 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2014-06-09
PMA P130008 INSPIRE MEDICAL SYSTEMS	INSPIRE II UPPER AIRWAY STIMULATOR	2014-04-30

Similar & Related FDA Registered Companies

Inspire Medical Systems Inc.
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS093 Date Received11/18/2022 Decision Date12/16/2022 Product Code MNQ Advisory Committee Anesthesiology Clinical TrialsNCT04457154 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS088 Date Received07/29/2022 Decision Date08/19/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS084 Date Received05/20/2022 Decision Date06/16/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS083 Date Received03/15/2022 Decision Date04/07/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS082 Date Received03/02/2022 Decision Date04/01/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS080 Date Received02/17/2022 Decision Date03/16/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS081 Date Received02/17/2022 Decision Date03/14/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS079 Date Received02/11/2022 Decision Date03/10/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

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