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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,VITATRON PIROUET LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
Applicant MEDTRONIC INC.
PMA NumberP930039
Supplement NumberS088
Date Received04/30/2013
Decision Date05/29/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Update to the maximum sterilization load profile temperature.
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