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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, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, MODEL 4195 ATTAIN SUREFIX LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
ApplicantMEDTRONIC, INC.
PMA NumberP930039
Supplement NumberS115
Date Received08/08/2014
Decision Date08/29/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update to the final packaging line for the devices.
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