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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 Programmer System
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS056
Date Received07/31/2020
Decision Date02/12/2021
Product Code MNQ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for:1) Updated version of the Model 2740 Inspire Programmer System;2) Minor software changes to the Application Module (AM)/Tablet;3) Manufacturing process changes to reduce scrap for the new programmer cable;4) Changes to improve aesthetics of the programmer cable; and5) Minor software updates regarding non-English languages for the European market and minor bug fixes.
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