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 | S036 |
Date Received | 05/10/2017 |
Decision Date | 06/09/2017 |
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 New component supplier for the polyether ether ketone (PEEK) overmold component of the Esteem Model 7004/7010 Sensor assemblies and Model 7504/7510 Driver assemblies. |
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