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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceInspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS084
Date Received05/20/2022
Decision Date06/16/2022
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Notification of replacing obsolete Metal- Oxide- Semiconductor Field-Effect Transistor (MOSFET) for the Sensor Assembly and additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the leads for the Inspire Models 4340 and 4063 Respiratory Sensing Leads
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