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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.
 
DeviceEASYTRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS025
Date Received03/10/2004
Decision Date08/06/2004
Product Code NIK 
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 CHANGES IN FIXATION DESIGN, LEAD LENGTHS AND ENABLING BIPOLAR PACE/SENSE CAPABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK 3 AND IS INDICATED FOR CHRONIC, LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS, WHEN USED IN CONJUNCTION WITH A COMPATIBLE GUIDANT CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE.
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