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 | S118 |
Date Received | 08/21/2015 |
Decision Date | 09/18/2015 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN LOCATION OF THE SUPPLIER OF RAW POLYETHYLENE MATERIALUSED TO MANUFACTURE BRAIDED FIBER THAT IS THEN USED IN THE HIRES 90KTM ADVANTAGE ANTENNA COIL, AND EXPANDED MATERIAL SPECIFICATIONS FOR BOTH THE RAW FIBER AND THE BRAIDED FIBER. |
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