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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
PMA NumberP890003
Supplement NumberS078
Date Received10/05/2004
Decision Date10/25/2004
Product Code
DXY[ Registered Establishments with DXY ]
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 the model 2490e & 2490d carelink monitors and model 2491 ddma software to allow their use with insync ii protect model 7295, insync maximo model 7303, onyx vr model 7290cx, intrinsic 30 model 7287 and intrinsic model 7288 implantable devices. The carelink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.