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 | S039 |
Date Received | 02/18/2009 |
Decision Date | 04/30/2009 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES MADE TO THE FOLLOWING USER MANUALS: DIB II (DIAGNOSTIC INTERFACE BOX), OPUS 1, OPUS 2 AND TEMPO+ SPEECH PROCESSORS, RBP (REMOTE BATTERY PACK) AND MICROPHONE TEST DEVICE (MTD). |
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