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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.
 
DeviceSYNERGYST II PULSE GENERATOR
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS071
Date Received08/19/2003
Decision Date09/17/2003
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 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE INSYNC ICD MODEL 7272 & INSYNC MARQUIS MODEL 7277. 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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