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 | CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S031 |
Date Received | 05/23/2003 |
Decision Date | 06/06/2003 |
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 CHANGES TO THE FOLLOWING PARTS OF THE BEHIND-THE-EAR (BTE) SOUND PROCESSOR: 1) THE TOGGLE SWITCH, 2) THE BTE BATTERY, 3) THE ACCESSORIES AVAILABLE WITH THE CURRENT BTE, 4) THE NEW ACCESSORY ITEMS, 5) THE AURIA HEADPIECE, AND 6) THE ESD WARNING IN THE PACKAGE INSERT. |
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