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 |
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 | S033 |
Date Received | 10/28/2016 |
Decision Date | 01/26/2017 |
Product Code |
OAF |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the header connector design of the Esteem Model 2001 Sound Processor and for manufacturing process improvements. |
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