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 | THE MED-EL C40 + COCHLEAR IMPLANT |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S085 |
Date Received | 02/01/2016 |
Decision Date | 04/29/2016 |
Product Code |
MCM |
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 labeling the MED-EL C40+ cochlear implant as conditionally safe for 1.5 Tesla in magnetic resonance (MR) environments, and updating the C40+ labeling with information on radiation therapy and scuba diving for patients and professionals. |
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