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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 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedevice resynchronization therapy-defibrillator (crt-d) system
PMA NumberP010012
Supplement NumberS022
Date Received01/16/2004
Decision Date02/12/2004
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify lead manuals.