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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 cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
PMA NumberP980016
Supplement NumberS047
Date Received01/21/2005
Decision Date03/31/2005
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the models 2490g and 2490j carelink monitors and model 2491 ddma software for use with the insync sentry model 7297, 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.