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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 GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980050
Supplement NumberS024
Date Received06/12/2006
Decision Date09/13/2006
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE POST APPROVAL STUDY TO UPDATE THE RESPECT STUDY PROTOCOL AND RELATED DOCUMENTATION TO INCORPORATE THE ENRHYTHM DEVICE (MODEL P15001DR), THE ENRHYTHM SOFTWARE (MODEL 9987), AND THE INCHECK PATIENT ASSISTANT (MODEL 2696).
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