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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.
 
DeviceKAINOX RV-S/ KAINOX VCS ICD LEADS
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS009
Date Received06/04/2002
Decision Date11/25/2002
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 THE KAINOX RV-S ACTIVE FIXATION, SINGLE SHOCK COIL ICD LEAD AND THE KAINOX VCS SINGLE SHOCK COIL ICD LEAD FOR USE AS AN ADJUNCT TO MODIFY THE SHOCK CONFIGURATION OF ICD SYSTEMS. TOGETHER WITH LEGALLY MARKETED BIOTRONIK ICDS, THESE LEAD SYSTEMS PROVIDE THE PATIENT WITH A SYSTEM THAT IS CAPABLE OF DETECTING AND TREATING VENTRICULAR TACHYARRHYTHMIAS.
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