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(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S004 |
Date Received | 12/23/1997 |
Decision Date | 03/17/1998 |
APCB Date
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10/18/2002 |
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 of a modified ICS lead electrode, i.e., the Flex Lead Electrode. |
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