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 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 | S038 |
Date Received | 08/28/2019 |
Decision Date | 09/26/2019 |
Product Code |
OAF |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change in a component supplier for the Model 7010 Sensor and Model 7510 Driver transducers. |
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