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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.
 
DeviceGEM FAMILY MODEL 7227
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP900061
Supplement NumberS063
Date Received02/21/2006
Decision Date04/21/2006
Product Code LWS 
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 SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER. SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM).
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