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 MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE |
Applicant | ADVANCED BIONICS 28515 WESTINGHOUSE PLACE VALENCIA, CA 91355 |
PMA Number | P960058 |
Supplement Number | S005 |
Date Received | 06/30/1998 |
Decision Date | 09/04/1998 |
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 question and answer has been affixed to page 29: "Are there any restriction 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, such as using a protective helmet, to reduce the risk of device failure." |
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