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 | HARMONY HIRESOLUTION BIONIC EAR SYSTEM |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S094 |
Date Received | 11/02/2011 |
Decision Date | 04/02/2012 |
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 A NEW ACCESSORY, CALLED T -COMM, FOR ADVANCED BIONICS BODY-WORN SOUND PROCESSORS. THIS ACCESSORY ALLOWS THE USE OF THE CURRENTLY-APPROVED T-MIC TO BE USED WITH THE BODY-WORN SOUND PROCESSORS. THE T-COMM ALSO INCORPORATES A TELECOIL. A SWITCH ALLOWS THE USER TO SELECT BETWEEN T-MIC, TELECOIL, OR A 50/50 MIX OF THE TWO INPUTS. |
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