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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 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC CRV
PMA NumberP010012
Supplement NumberS302
Date Received09/04/2012
Decision Date10/03/2012
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the dexamethasone acetate drug substance specification and testing.
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