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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 NameSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
ApplicantMEDTRONIC, INC.
PMA NumberP930039
Supplement NumberS119
Date Received09/15/2014
Decision Date10/14/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Outsource the supply of three molded components used in the manufacture of the lead models.
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