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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 3 IS-1 LEAD MODELS: 4548/4549/4550
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedevice resynchronization therapy-defibrillator (crt-d) system
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS032
Date Received09/23/2004
Decision Date11/24/2004
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change of lead connector from lv-1 to is-1.
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