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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 VISION SOFTWARE SERIES 4.0
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS017
Date Received02/22/2001
Decision Date03/15/2001
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the programming software to be used with the medtronic gem dr (model 9960 software), gemii vr (model 9965 software), and gem ii dr (model 9964 software) icd systems. The device, as modified, will be marketed under the trade name of medtronic vision software series 4. 0.
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