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 DEVICE FITTING SOFTWARE (SCLIN) |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S011 |
Date Received | 03/24/1999 |
Decision Date | 07/16/1999 |
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 modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. |
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