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 | S030 |
Date Received | 09/23/2015 |
Decision Date | 03/18/2016 |
Product Code |
OAF |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective. |
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