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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 IS-1 AND EASYTRAK LV-1 LEADS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS139
Date Received09/11/2006
Decision Date03/06/2007
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING POST APPROVAL STUDY (PAS) DATA TO THE EASYTRAK IS-1 AND EASYTRAK LV-1 PHYSICIAN MANUALS.
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