PMA P130008S027

Device
Inspire IV IPG
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S027
Product code
MNQ
Decision date
2017-11-08
Classification
Stimulator, Hypoglossal Nerve, Implanted, Apnea
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement
Changes to update to software version 1.0.4 of the Serial Number Verification System for the Model 3028 IPG.
Summary
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Current openFDA PMA Record#

Device
Inspire IV IPG
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S027
Product code
MNQ
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Decision date
2017-11-08
Decision code
OK30
Date received
2017-10-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to update to software version 1.0.4 of the Serial Number Verification System for the Model 3028 IPG.