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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 WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardoverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980050
Supplement NumberS024
Date Received06/12/2006
Decision Date09/13/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
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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