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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.
 
DeviceMEDTRONIC MODEL 2090 CARELINK PROGRAMMER WITH TELEMETRY C
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS080
Date Received12/06/2004
Decision Date02/18/2005
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 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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