|
Device | AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM |
Generic Name | implant, cochlear |
Applicant | ADVANCED BIONICS 28515 westinghouse place valencia, CA 91355 |
PMA Number | P960058 |
Supplement Number | S090 |
Date Received | 06/09/2011 |
Decision Date | 09/12/2011 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 135 review track for 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE THICKNESS TO DIELECTRIC LAYERS OF THE SUBSTRATE AND IS INDICATED TO PROVIDE USEFUL HEARING TO INDIVIDUALS WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS. |