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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 MODEL 7227 ICD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP900061
Supplement NumberS056
Date Received03/27/2002
Decision Date04/16/2002
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EXPANSION OF THE FUNCTIONALITY OF THE MODEL 2490A CARELINK MONITOR AND MODEL 2491 SOFTWARE, VERSION 1.0 TO INCLUDE THE GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR AND GEM III DR IMPLANTABLE CARDIOVETER DEFIBRILLATORS.
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