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 | Neuro Cochlear Implant System |
Generic Name | Implant, cochlear |
Applicant | Oticon Medical 2720 Chemin Saint Bernard Vallauris 06220 |
PMA Number | P200021 |
Supplement Number | S003 |
Date Received | 08/11/2021 |
Decision Date | 09/08/2021 |
Product Code |
MCM |
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 Modification to the acceptance criteria for the incoming screening test of each CI-Link unit when they are received by Oticon Medical from the supplier. |
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