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 | S162 |
Date Received | 07/14/2023 |
Decision Date | 01/10/2024 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval of a new sterilizer at the AB Valencia facility and approval of the adoption of the HiFocus™ Mid-Scala Electrode Insertion Tool Kit and HiFocus™ Mid-Scala Electrode Insertion Tool into the Implantable Cochlear System (ICS) family of devices. |
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