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 | MED-EL COCHLEAR IMPLANT SYSTEMS |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S059 |
Date Received | 10/17/2011 |
Decision Date | 12/16/2011 |
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 THE OPUS 2 BATTERY PACK XS WHICH IS AN ADDITIONAL OPTIONAL BATTERY PACK FOR USE WITH THE FOLLOWING APPROVED AUDIO PROCESSORS OF THE MED-EL COCHLEAR IMPLANT (CI) SYSTEM: TEMPO+, OPUS 1 AND OPUS 2. |
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