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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 NameCARELINK MONITORS 2490H, AND MODEL 2020A CARDIOSIGHT READER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS109
Date Received10/03/2006
Decision Date10/20/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for electrical safety instructions for the carelink monitor.
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