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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 NameCAPSURE EPICARDIAL PACKING LEAD
Classification Namepermanent defibrillator electrodes
Generic Namecapsure epi epicardial steroid eluting pacing lead
ApplicantMEDTRONIC, INC.
PMA NumberP950024
Supplement NumberS046
Date Received11/21/2012
Decision Date12/20/2012
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 
Implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.
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