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 | BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC) |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S022 |
Date Received | 05/28/2002 |
Decision Date | 06/06/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE BTE SYSTEM SENSOR, AN ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR FOR LIMITED VERIFICATION OF SYSTEM FUNCTIONALITY. |
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