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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 GEM III AT MODEL 7276 (ICD)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cdardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980050
Supplement NumberS002
Date Received11/06/2000
Decision Date02/13/2001
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 the medtronic gem iii at model 7276 implantable cardioverter defibrillator with the model 9465 patient assistant.
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