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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.
 
DeviceCAPSURE SENSE LEAD MODELS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP830061
Supplement NumberS034
Date Received03/01/2002
Decision Date07/23/2002
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR PACING LEADS THAT INCORPORATE A NEW SURFACE COATING, A NEW ELECTRODE GEOMETRY, A NEW COMBINATION OF PREVIOUSLY USED STEROIDS, AND A NEW TAPERED STYLET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE SENSE LEAD MODELS 4074/4574/4073 AND THE VITATRON CRYSTALLINE LEAD MODELS ICM09B, ICM09JB, AND ICM09. THESE DEVICES ARE INDICATED FOR PACING OR SENSING IN THE ATRIUM OR VENTRICLE. THE LEADS HAVE APPLICATION WHERE IMPLANTABLE ATRIAL OR VENTRICULAR SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.
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