Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead

FDA Premarket Approval P130008 S084

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

DeviceInspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead
Generic NameStimulator, Hypoglossal Nerve, Implanted, Apnea
ApplicantINSPIRE 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
Date Received2022-05-20
Decision Date2022-06-16
PMAP130008
SupplementS084
Product CodeMNQ 
Advisory CommitteeAnesthesiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressINSPIRE MEDICAL SYSTEMS
9700 63rd Avenue North
suite 200
maple 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 Combination ProductNo Approval Order Statement  
Notification Of Replacing Obsolete Metal- Oxide- Semiconductor Field-Effect Transistor (MOSFET) For The Sensor Assembly And Additional Lathe Equipment To Be Used To Manufacture The Terminal Pin Used In The Connector Assembly Of The Leads For The Inspire Models 4340 And 4063 Respiratory Sensing Leads

Supplemental Filings

Supplement NumberDateSupplement Type
P130008Original Filing
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
00855728005093 P130008 001
10855728005199 P130008 001
10855728005182 P130008 001
00855728005000 P130008 001
00855728005017 P130008 001
00855728005024 P130008 001
00855728005031 P130008 001
00855728005055 P130008 001
00855728005185 P130008 001
00855728005192 P130008 001
00855728005109 P130008 002
00855728005437 P130008 008
00855728005611 P130008 009
00855728005598 P130008 009
00855728005222 P130008 009
00855728005253 P130008 009
00855728005277 P130008 013
00855728005307 P130008 013
00855728005338 P130008 013
00855728005413 P130008 013
10855728005410 P130008 013
10855728005366 P130008 016
10855728005403 P130008 016
10855728005397 P130008 016
10855728005533 P130008 016
10855728005465 P130008 021
10855728005496 P130008 023
10855728005526 P130008 023
10855728005458 P130008 031
10855728005892 P130008 031
10855728005632 P130008 031
00855728005642 P130008 034
00855728005550 P130008 034
00855728005826 P130008 034
10855728005656 P130008 037
10855728005762 P130008 039
10855728005670 P130008 041
10855728005809 P130008 041
10855728005915 P130008 055
00855728005741 P130008 056
00810098650007 P130008 068
00855728005925 P130008 069

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