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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Device2490D/E CARELINK MONITORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS078
Date Received10/05/2004
Decision Date10/25/2004
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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