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 | S006 |
Date Received | 06/30/1998 |
Decision Date | 09/04/1998 |
APCB Date
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10/18/2002 |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following questioin and answer has been afixed to page 29: "Are there any restrictions on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, sucha s using a protective helmet to reduce the risk of device failure." |
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