FDA.reportPublic FDA data

PMA P130008S054

Device
Inspire Respiratory Sensing Lead
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S054
Product code
MNQ
Decision date
2020-07-20
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement
Changes to the manufacturing of Model 4340 respiratory sensing lead involving the addition of a new MRSI Die Bonder for Hermetic Pressure Sensor Assembly Membrane and Network die bonding process.

Current openFDA PMA Record#

Device
Inspire Respiratory Sensing Lead
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S054
Product code
MNQ
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Decision date
2020-07-20
Decision code
OK30
Date received
2020-06-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the manufacturing of Model 4340 respiratory sensing lead involving the addition of a new MRSI Die Bonder for Hermetic Pressure Sensor Assembly Membrane and Network die bonding process.