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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 NameKENTROX SL ICD LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS016
Date Received09/16/2003
Decision Date03/12/2004
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in component dimensions. The device, as modified, will be marketed under the trade name kentrox sl and is indicated for use in conjunction with a biotronik icd. Currently, data is not available regarding the use of this lead system with icds of other manufacturers. Use of other icds may adversely affect sensing and/or therapy delivery.
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