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PMA P130008S048

Device
Implantable Pulse Generator, Sensing Lead, and Stimulation Lead
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S048
Product code
MNQ
Decision date
2020-01-10
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement
Updated molding process for the clamping rod of tunneling tool, which is used to tunnel the lead connector from the point of implantation to the IPG pocket.

Current openFDA PMA Record#

Device
Implantable Pulse Generator, Sensing Lead, and Stimulation Lead
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S048
Product code
MNQ
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Decision date
2020-01-10
Decision code
OK30
Date received
2019-12-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updated molding process for the clamping rod of tunneling tool, which is used to tunnel the lead connector from the point of implantation to the IPG pocket.