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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 NameMEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS035
Date Received02/12/2004
Decision Date03/08/2004
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 2490d carelink monitor and model 2491 ddma software to allow their use with enpulse and kappa 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.
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