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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 MODEL 7227 ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS056
Date Received03/27/2002
Decision Date04/16/2002
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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