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 |
Generic Name | implant, cochlear |
Applicant | ADVANCED BIONICS 28515 westinghouse place valencia, CA 91355 |
PMA Number | P960058 |
Supplement Number | S095 |
Date Received | 12/30/2011 |
Decision Date | 06/15/2012 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ADVANCED BIONICS, LLC AND A FINISHED GOODS WAREHOUSE LOCATED IN VALENCIA, CALIFORNIA. |
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