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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 PACING LEAD DRUG COMBINATION
Classification Namepermanent defibrillator electrodes
Generic Namecapsure epi epicardial steroid eluting pacing lead
Applicant MEDTRONIC INC.
PMA NumberP950024
Supplement NumberS027
Date Received11/12/2010
Decision Date12/08/2010
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 
Update to supplier quality software.
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