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 COMBI 40+ |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S010 |
Date Received | 06/16/2003 |
Decision Date | 07/25/2003 |
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 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE THE FOLLOWING ACCESSORIES FOR THE TEMPO+ SPEECH PROCESSOR: TELEMIC AND MICROPHONE TEST DEVICE (MTD). THE TELEMIC IS INDICATED FOR THE COMBI 40+ COCHLEAR IMPLANT USER WHO DESIRES EITHER A DIRECT CONNECTION TO A TELEPHONE OR AN INDUCTION LOOP OR ADDITIONAL AMPLIFICATION OF THE TEMPO+ SPEECH PROCESSOR INTERNAL MICROPHONE. THE MTD IS INDICATED FOR INDIVIDUALS WHO WISH TO QUALITATIVELY MONITOR THE MICROPHONE SIGNAL OF THE TEMPO+ SPEECH PROCESSOR. |
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