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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 STARFIX LEAD
Classification Namepermanent defibrillator electrodes
Generic Namelv lead
Applicant MEDTRONIC INC.
PMA NumberP060039
Supplement NumberS059
Date Received06/26/2014
Decision Date09/04/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updates to the finished product release criteria for content uniformity and elution for the attain starfix model 4195 lead.
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