Inspire Upper Airway Stimulation

FDA Premarket Approval P130008 S052

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 of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p130008/s039.

DeviceInspire Upper Airway Stimulation
Generic NameStimulator, Hypoglossal Nerve, Implanted, Apnea
ApplicantINSPIRE MEDICAL SYSTEMS
Date Received2020-05-14
Decision Date2020-06-12
PMAP130008
SupplementS052
Product CodeMNQ 
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
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
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
00855728005000 P130008 001
00855728005093 P130008 001
00855728005185 P130008 001
00855728005192 P130008 001
00855728005031 P130008 001
00855728005024 P130008 001
00855728005017 P130008 001
10855728005199 P130008 001
10855728005182 P130008 001
00855728005055 P130008 001
00855728005109 P130008 002
00855728005437 P130008 008
00855728005222 P130008 009
00855728005598 P130008 009
00855728005611 P130008 009
00855728005253 P130008 009
00855728005307 P130008 013
00855728005277 P130008 013
00855728005338 P130008 013
00855728005413 P130008 013
10855728005410 P130008 013
10855728005366 P130008 016
10855728005533 P130008 016
10855728005397 P130008 016
10855728005403 P130008 016
10855728005465 P130008 021
10855728005632 P130008 031
00855728005550 P130008 034
00855728005642 P130008 034
10855728005656 P130008 037
10855728005670 P130008 041

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