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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS005
Date Received06/30/1998
Decision Date09/04/1998
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - instructions
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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