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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 EPI EPICARDIAL PACING LEADS
Classification Namepermanent defibrillator electrodes
Generic Namecapsure epi epicardial steroid eluting pacing lead
Applicant MEDTRONIC INC.
PMA NumberP950024
Supplement NumberS036
Date Received08/22/2011
Decision Date09/21/2011
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 
New process settings established for a blister sealer machine.
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