|
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 | S008 |
Date Received | 09/03/1998 |
Decision Date | 02/19/1999 |
APCB Date
|
10/18/2002 |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium. |