|
Device | CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S007 |
Date Received | 09/03/1998 |
Decision Date | 02/19/1999 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium. |