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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 NameCOMBO 40+ COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS023
Date Received03/29/2007
Decision Date09/24/2007
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the opus-1 external speech processor and the maestro 2. 0. 1, which are new components of the approved combi 40+ cochlear implant system and are indicated for use on patients who have been implanted with pulsarci100 and/or sonatati100 cochlear implants. The software, maestro 2. 0. 1, is intended for programming the opus-1 speech processor, and implements two new speech coding strategy features, high definition cis (hdcis) and fine structure processing (fsp).
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