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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.
 
DeviceSELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
Generic Namepermanent pacemaker Electrode
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS034
Date Received07/14/2003
Decision Date03/08/2004
Product Codes DTB DXY 
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 ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX SR AND IS INDICATED AS FOLLOWING: BOTRONIK'S SELOX SR TRANSVENOUS, STEROID-ELUTING, ACTIVE FIXATION ENDOCARDIAL LEADS ARE INDICATED FOR PERMANENT PACING AND SENSING. ACTIVE FIXATION PACING LEADS WITH A BIPOLAR (BP) IS-1 CONNECTOR CONFIGURATION ARE DESIGNED FOR USE IN CONJUNCTION WITH IMPLANTABLE PULSE GENERATORS WITH IS-1 HEADERS. THE LEADS MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS. THE SELOX SR LEAD MODELS ARE INTENDED FOR PLACEMENT IN EITHER THE RIGHT ATRIUM OR RIGHT VENTRICLE.
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