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/AIM System |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S133 |
Date Received | 10/16/2018 |
Decision Date | 04/12/2019 |
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 |
Approval Order Statement Approval for the AIM System components (with model numbers): AIM System (tablet) Cl-6126, AIM Power Adapter Cl-6132, AIM Sterile Inserts Cl-6120, AIM Tablet Power Cord (US) Cl-6127, AIM Programming Cable Cl-6125, AIM Software Cl-6056-001, AIM Insert Earphone Cl-6129, and AIM Rechargeable Battery Cl-6130. |
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