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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.
 
DeviceCAPSURE EPI UNIPOLAR/BIPOLAR LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP950024
Supplement NumberS030
Date Received04/12/2011
Decision Date05/12/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the nelipak sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test.
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