Premarket Approval (PMA)

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.

• Device: Inspire II Upper Airway Stimulator
• Generic Name: Stimulator, hypoglossal nerve, implanted, apnea
• Applicant: Inspire Medical Systems; 9700 63rd Ave. N., Suite 200; Maple Grove, MN 55369
• PMA Number: P130008
• Supplement Number: S022
• Date Received: 03/29/2017
• Decision Date: 09/11/2017
• Product Code: MNQ
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.