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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 STARFIX MODEL 4195 LEADS
Classification Namepermanent defibrillator electrodes
Generic Namelv lead
Applicant MEDTRONIC INC.
PMA NumberP060039
Supplement NumberS056
Date Received02/07/2014
Decision Date08/04/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Clinical Trials NCT00893386
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the heartmate ii lvas instructions for use to include the post-approval study results for the destination therapy indication and to add a discussion on pump thrombosis.
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