Trade Name | HIRESOLUTION BIONIC EAR SYSTEM |
Classification Name | implant, cochlear |
Generic Name | cochlear implant (pediatric) |
Applicant | ADVANCED BIONICS CORP. |
PMA Number | P960058 |
Supplement Number | S034 |
Date Received | 03/03/2004 |
Decision Date | 07/19/2004 |
Product Code |
|
Advisory Committee |
Ear Nose & Throat
|
Supplement Type |
normal 180 day track |
Supplement Reason | change design/components/specifications - component |
Expedited Review Granted? |
No
|
Approval Order Statement
Approval for an alternate electrode configuration for the hires90k implant.
This alternate electrode is a modified version of the current hifocus electrode, identified as hifocus helix electrode.
|