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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/ATTAIN ABILITY PLUS/ATTAIN ABILITY STRAIGHT
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP080006
Supplement NumberS036
Date Received11/21/2011
Decision Date02/28/2013
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 the model 080118 medical adhesive used as an accessory for the attain ability, attain ability plus, and attain ability straight left ventricular leads.
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