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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 LEAD MODELS 4510, 4511, 4512 AND 4513 CORONARY VENOUS STEROID ELUTING SINGLE-ELECTRODE PACE/SENSE LEADS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS003
Date Received07/26/2002
Decision Date01/22/2003
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING A POLYURETHANE SLEEVE OVER THE SILICONE INSULATION IN THE TERMINAL CONNECTOR AREA AND MINOR CHANGES TO IMPROVE LEAD MANUFACTURABILITY.
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