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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 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.
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS002
Date Received07/20/1998
Decision Date07/22/1998
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two minor design changes to the ESPrit (ear level) speech processor: 1) the addition of a 47uF capacitor; and 2) the lowering of the crystal Q with insertion of a low value resistor (R3-120). As stated in the submission and described in the telephone conference on July 22, 1998, these two changes have been tested and validated. With reference to item 1), this change would lower the total harmonic distoriton resulting in improved audio signal. In item 2) you would improve the oscillator stability over a specified temperature range resulting in better production yield.