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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 NameSELECTSECURE LEAD MODEL 3830 TECHNICAL MANUAL
Classification Namepermanent defibrillator electrodes
Applicant MEDTRONIC INC.
PMA NumberP030036
Supplement NumberS053
Date Received02/01/2013
Decision Date02/28/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 2 content changes in the selectsecure lead model 3830 technical manual.
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