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 | HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K) |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S030 |
Date Received | 03/18/2003 |
Decision Date | 07/07/2003 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE REPACKAGED ICS (IMPLANTABLE COCHLEAR STIMULATOR), REFERRED TO AS HIRES 90K, AND ITS ASSOCIATED SURGICAL TOOLS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS OF AGE. |
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