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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 NameACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namecardiac resynchronization therapy-defibrillator
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP010012
Supplement NumberS315
Date Received11/14/2012
Decision Date12/20/2012
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an alternate primer material.
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