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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 NameMEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS259
Date Received09/04/2012
Decision Date04/03/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the evera implantable cardioverter defibrillators.
Approval Order Approval Order
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