|
Device | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S005 |
Date Received | 03/30/1998 |
Decision Date | 05/28/1998 |
APCB Date
|
10/18/2002 |
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 modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the CIM 3. |