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 | CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S014 |
Date Received | 03/22/2000 |
Decision Date | 07/13/2000 |
APCB Date
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10/18/2002 |
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 CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR POST-LINGUAL SEVERE TO PROFOUND HEARING LOSS WHERE LIMITED BENEFIT HAS BEEN OBTAINED WITH THE USE OF HEARING AIDS. |
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