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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 NameMYCARELINK MONITOR,
Classification Namepulse generator, permanent, implantable
ApplicantMEDTRONIC, INC.
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 - software
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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