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. |
|
Device | NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S011 |
Date Received | 07/21/2000 |
Decision Date | 11/01/2000 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATION OF THE ELECTRODE FOR THE NUCLEUS CI24 COCHLEAR IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM WITH THE FOLLOWING CHANGES TO THE INDICATIONS FOR USE: 1) APPROVAL TO IMPLANT INDIVIDUALS, AGE 18 YEARS AND OLDER, WHO OBTAIN LIMITED BENEFIT FROM AMPLIFICATION AS DEFINED BY TEST SCORES OF <=50% CORRECT IN THE EAR TO BE IMPLANTED, (<=60% IN THE BEST AIDED LISTENING CONDITION) ON TAPE RECORDED TESTS OF OPEN SET SENTENCE RECOGNITION. 2) APPROVAL TO IMPLANT CHILDREN 12 MONTHS OF AGE AND OLDER WHO HAVE BILATERAL PROFOUND SENSORINEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS. |
|
|