PMA P130008S034

Device
Inspire Model 2740 Physician Programmer
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S034
Product code
MNQ
Decision date
2018-11-01
Classification
Stimulator, Hypoglossal Nerve, Implanted, Apnea
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement
Approval for an update to the tablet hardware and software of the Model 2740 Physician Programmer.

Current openFDA PMA Record#

Device
Inspire Model 2740 Physician Programmer
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S034
Product code
MNQ
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Decision date
2018-11-01
Decision code
APPR
Date received
2018-04-16
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an update to the tablet hardware and software of the Model 2740 Physician Programmer.