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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.
 
DeviceSETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60)
Generic NamePulse generator, permanent, implantable
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS042
Date Received11/09/2005
Decision Date02/14/2006
Product Code NVZ 
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 SELOX SR PACING LEAD FAMILY TO CHANGE THE STEROID DOSAGE, MAXIMUM LEAD BODY DIAMETER, AND RING ELECTRODE BASE MATERIAL, AS WELL AS OTHER MINOR CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD AND IS INDICATED FOR PERMANENT PACING AND SENSING.
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