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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 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.
 
DeviceKENTROX RV LEAD SYSTEMS
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS007
Date Received01/22/2002
Decision Date02/21/2002
Product Codes DTA DTE KRG LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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