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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 II Upper Airway Stimulator
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS055
Date Received07/10/2020
Decision Date11/16/2020
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of manufacturing site located at Cirtec Medical, 99 Print Shop Rd, Enfield, CT 06082, USA, (for sterilization process for the finished device, Inspire Model 3028 IPG).
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