PMA P130008S067

Device
Inspire Upper Airway Stimulation (UAS)
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S067
Product code
MNQ
Decision date
2021-06-24
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement
Modifications to the strain relief molding tool used to manufacture power and antenna cable assemblies for the Model 2740 Programmer Cable.

Current openFDA PMA Record#

Device
Inspire Upper Airway Stimulation (UAS)
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S067
Product code
MNQ
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Decision date
2021-06-24
Decision code
OK30
Date received
2021-05-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifications to the strain relief molding tool used to manufacture power and antenna cable assemblies for the Model 2740 Programmer Cable.