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 CII BIONIC EAR SYSTEM (PEDIATRIC) |
Generic Name | implant, cochlear |
Applicant | ADVANCED BIONICS 28515 westinghouse place valencia, CA 91355 |
PMA Number | P960058 |
Supplement Number | S026 |
Date Received | 10/25/2002 |
Decision Date | 11/01/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | real-time process |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO THE POSTMARKET STUDY PROTOCOL: 1) USE OF ONLY THE PB-K TEST TO DETERMINE CANDIDACY IN CHILDREN 4 YEARS THROUGH 17 YEARS OF AGE AT TIME OF IMPLANT. 2) SUBSTITUTION OF THE PB-K TEST FOR THE ESP TEST AS AN OUTCOME MEASURE. 3) DIVISION OF THE YOUNGEST AGE GROUP INTO TWO GROUPS. 4) ADDITIONAL INCLUSION/EXCLUSION CRITERIA FOR ADULTS AND CHILDREN. |
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