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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 NameCOMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS019
Date Received07/07/2005
Decision Date07/25/2005
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the combi 40+ system with c40+ or pulsarci100 cochlear implants to update non-essential labeling and a manual for troubleshooting fm systems which may be used ith the tempo+.
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