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) |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S025 |
Date Received | 09/19/2002 |
Decision Date | 09/23/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE PRODUCT NAME OF THE HIRES SOFTWARE, MODEL NUMBER CI-6055. THE SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE, MODEL NUMBER CI-6055, AND IS INDICATED FOR USE IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12 MONTHS TO 17 YEARS, 11-MONTHS OF AGE). |
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