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 | Esteem® Totally Implantable Hearing System |
Generic Name | Implant, hearing, active, middle ear, totally implanted |
Applicant | ENVOY MEDICAL CORPORATION 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE, MN 55110 |
PMA Number | P090018 |
Supplement Number | S041 |
Date Received | 03/23/2022 |
Decision Date | 08/24/2022 |
Product Code |
OAF |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of final labeling changes for the post-approval study (PAS) referenced above. The updates to the final PAS labeling have been submitted to comply with the conditions of approval outlined in our approval order for P090018. |
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