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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMED-EL COMBI 40+
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS010
Date Received07/02/2003
Decision Date07/25/2003
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
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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