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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
Classification Namepermanent defibrillator electrodes
Generic Namepacing lead
ApplicantMEDTRONIC, INC.
PMA NumberP930039
Supplement NumberS109
Date Received05/22/2014
Decision Date06/17/2014
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 Yes
Approval Order Statement 
Minor change to the plasma treatment and spooling process used on silicone tubing which is used as insulation in the impacted lead model.
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