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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMYCARELINK MONITOR,
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP890003
Supplement NumberS295
Date Received12/16/2013
Decision Date02/27/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE DEVICES.
Approval Order Approval Order
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