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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 Name2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS082
Date Received01/31/2005
Decision Date07/26/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic 2020a cardiosight reader and the model 2491 device data management application (ddma) software for use in the transfer of patient and device data.
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