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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 NameATTAIN ABILITY MODEL 4X96 LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP080006
Supplement NumberS063
Date Received11/27/2013
Decision Date05/15/2014
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the monolithic controlled release device (mcrd) elution method and specifications, transfer of the mcrd manufacturing location, use of a surrogate tip component for mcrd testing, and updates to the mcrd shelf life protocol for attain ability lead models 4196, 4296 and 4396.
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