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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 IMPLANTABLE PULSE GENERATOR
Generic NameStimulator, hypoglossal nerve, implanted, apnea
ApplicantInspire Medical Systems
9700 63rd Ave. N., Suite 200
Maple Grove, MN 55369
PMA NumberP130008
Supplement NumberS015
Date Received09/14/2016
Decision Date10/14/2016
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  
Implement a change to the manufacturing procedure for annealing of the Model 3024 implantable pulse generator (IPG), which adds an in-house annealing process at 1st tier supplier Greatbatch Medical Minneapolis (GMM).
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