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 | S029 |
Date Received | 03/23/2015 |
Decision Date | 06/19/2015 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE TO THE UV EPOXY MATERIAL IN THE HEADER CONNECTOR OF THE SOUND PROCESSOR AND FOR A NEW PLASMA PRE-TREATMENT STEP TO ENHANCE ADHESION OF THE SILICONE DIP COATING. |
Post-Approval Study | Show Report Schedule and Study Progress |
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