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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS068
Date Received02/01/2006
Decision Date02/28/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for electrical safety instructions for the carelink monitor.
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