• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
400 inverness parkway,
suite 400
englewood, CO 80112
PMA NumberP840024
Supplement NumberS070
Date Received04/24/1997
Decision Date06/11/1997
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement a design change to the two-pin socket on the headset microphone. The transmitting coil is connected to the microphone via a cable which is plugged into this two-pinc socket. This change would also entail making a slight modification to the design of the shell of the headset microphone in order to accommodate the new design of the two-pin socket. The nucleus 22 channel cochlear implant is indicated for use in adults with bilateral, sensorineural, severe-to-profound deafness, ages 18 years and older, who obtain up to 30% speech recognition on tests of recorded sentence materials in the best-aided condition. It is indicated for use in children with bilateral, sensorineural, profound deafness, ages 2 years to 17 years, who obtain little or not benefit from conventional amplification in the best-aided test condition.
-
-