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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 NameDEVICE CARELINK ENCORE 29901 PROGRAMMER INCLUDING ACCESSORIES AND REVEAL DX, REVEAL XT (MODEL SW007 V8.0)
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS254
Date Received07/17/2012
Decision Date03/13/2013
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 Approval Order
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