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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 NameMEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cdardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980050
Supplement NumberS004
Date Received04/13/2001
Decision Date05/22/2001
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling for the model 7276 gem iii at implantable defibrillator which reflects the "af only" indication (i. E. , indicated for use in icd patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias).
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