Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S014 |
Date Received | 06/22/2000 |
Decision Date | 11/15/2000 |
Product Code |
MCM |
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 CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR PEDIATRIC USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE AND IS INDICATED FOR SEVERELY AND PROFOUNDLY HEARING IMPAIRED CHILDREN AGES 18-MONTHS TO 17-YEARS. |
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