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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 FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS019
Date Received12/19/2004
Decision Date07/18/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the kentrox family of implantable cardioverter defibrillator (icd) leads. The devices, as modified, will be marketed under the trade names kentrox rv, kentrox rv steroid, kentrox sl, kentrox sl steroid, kentrox rv-s, kentrox rv-s steroid, and kentrox sls steroid and are indicated for use in conjunction with a biotronik icd.
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