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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 2090 CARELINK PROGRAMMER WITH TELEMETRY C
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS080
Date Received12/06/2004
Decision Date02/18/2005
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of distance telemetry functionality to the currently approved programmer. The device, as modified, will be marketed under the trade name medtronic model 2090 carelink programmer with telemetry c and is indicated for use in the interrogation and programming of implantable medical devices.
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