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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 NameACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namesingle chamber, sensor driven, implantable pulse
Applicant MEDTRONIC INC.
PMA NumberP850051
Supplement NumberS080
Date Received04/18/2013
Decision Date06/11/2013
Product Code
LWP[ Registered Establishments with LWP ]
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 enhancements to model 9986 desktop/boss for use on the model 2090 medtronic carelink programmer for the devices.
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