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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 MONITOR MODEL 2490H
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP890003
Supplement NumberS119
Date Received05/29/2007
Decision Date05/13/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic adapta/versa/ sensia implantable pacemakers (a/v/s pacemakers), model sw003 application software, and model 2490h medtronic carelink monitor and model 2491 ddma software.
Post-Approval StudyShow Report Schedule and Study Progress
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