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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+COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant system
ApplicantMED-EL CORP.
PMA NumberP000025
Supplement NumberS017
Date Received01/11/2005
Decision Date07/10/2008
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for med-el combi 40+ cochlear implant system with pulsarci100 implants. The device, as modified, will be marketed under the trade name med-el combi 40+ cochlear implant system with pulsarci100 implants and is indicated for the following patient populations: 1) adults eighteen (18) years of age or older who have a severe to profound, bilateral sensonneural hearing loss and obtain limited benefit form appropriately fitted binaural hearing aids [note: this hearing loss may be evidenced by a bilateral pure tone average of 70 db or greater at 500, 1000 and 2000 hz and by best-aided score of <=40% correct on open-set hearing in noise test sentences (hint)]; 2) children twelve (12) months of age and older who demonstrate a profound, bilateral sensonneural hearing loss with thresholds of 90 db or greater at 1000 hz and obtain little to no benefit from appropriately fitted binaural hearing aids [note: this hearing loss in younger children may be evidenced by a lack of progress in simple auditory skill development, despite appropriate amplification and aural habitation, over a three to six-month period. This hearing loss in older children may be evidenced by a score of <20% correct on the mlnt or lnt].
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