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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.
 
DeviceTEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS005
Date Received06/25/2001
Decision Date10/24/2001
Product Codes DTA DTE KRG LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE LEGALLY MARKETED KAINOX RV AND KAINOX SL LEAD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEROX RV 65 (MODEL 332 232), TEROX RV 75 (MODEL 332 231),KAINOX SL 65/13 (MODEL 124 235),KAINOX SL 65/16 (MODEL 124 236), KAINOX SL 65/18 (MODEL 124 237), AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).
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