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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 NameCAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
Applicant MEDTRONIC INC.
PMA NumberP930039
Supplement NumberS085
Date Received04/09/2013
Decision Date12/24/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a re-packaging/re-labeling site located at medtronic in memphis, tennesee.
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