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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 NameMEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP080006
Supplement NumberS006
Date Received01/29/2010
Decision Date10/04/2012
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for component level analytical testing for release of the model 4196, 4296 and 4396.
Approval Order Approval Order
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