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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 RV LEAD SYSTEMS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator,pacemaker programmer;icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS007
Date Received01/22/2002
Decision Date02/21/2002
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a name change for the terox rv 65 and terox rv 75 leads. The device will now be marketed under the trade name kentrox rv 65 (model 332 232) and kentrox rv 75 (model 332 231) and is indicated for use with legally marketed biotronik implantable cardioverter defibrillators (icd).
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