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. |
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Device | INSPIRE II UPPER AIRWAY STIMULATOR |
Generic Name | Stimulator, hypoglossal nerve, implanted, apnea |
Applicant | INSPIRE MEDICAL SYSTEMS 9700 63RD AVENUE NORTH SUITE 200 MAPLE GROVE, MN 55369 |
PMA Number | P130008 |
Supplement Number | S002 |
Date Received | 06/30/2014 |
Decision Date | 02/05/2015 |
Product Code |
MNQ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN UPDATE TO THE TABLET HARDWARE AND OPERATING SYSTEM OF THE MODEL 2740 PHYSICIAN PROGRAMMER, AND RELATED CHANGES TO THE MODEL 2740 PROGRAMMER MANUAL. |
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