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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEASYTRAK IS-1 AND EASYTRAK LV-1 LEADS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS139
Date Received09/11/2006
Decision Date03/06/2007
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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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