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 | CLARION CII BIONIC EAR SYSTEM |
Generic Name | implant, cochlear |
Applicant | ADVANCED BIONICS 28515 westinghouse place valencia, CA 91355 |
PMA Number | P960058 |
Supplement Number | S023 |
Date Received | 07/29/2002 |
Decision Date | 09/09/2002 |
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 APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE). IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS. |
|
|