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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 STEROID ELUTING PACING LEAD
Classification Namepermanent defibrillator electrodes
Generic Namecapsure epi epicardial steroid eluting pacing lead
Applicant MEDTRONIC INC.
PMA NumberP950024
Supplement NumberS010
Date Received04/14/2008
Decision Date05/14/2008
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to the rice creek facility?s ethylene oxide (eto) sterilization exposure time for leads, pacing accessories, and adaptor products.
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