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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 NameVITATRON LEGACY, PREVAIL, PREMIER, & VARIOUS FAMILIES/MODELS OF ACTIVITRAX, LEGEND, MINIX
Classification Namepulse-generator, single chamber, sensor driven, implantable
Generic Namesingle chamber, sensor driven, implantable pulse
Applicant MEDTRONIC INC.
PMA NumberP850051
Supplement NumberS078
Date Received09/22/2011
Decision Date11/17/2011
Product Code
LWO[ Registered Establishments with LWO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the operating system software for the carelink programmer associated with medtronic pacemaker, implantable cardioverter defibrillator (icd), and cardiac resynchronization therapy (crt) devices approved under the referenced pma.
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