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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 FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS019
Date Received12/19/2004
Decision Date07/18/2005
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
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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