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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 JEWEL CARDIOVERTER DEFIBRILLATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namearrhythmia management devices
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS023
Date Received04/03/1996
Decision Date09/25/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 9895e application software, version t6e6v3, for model 9790 and 9790c programmers which program the models 7616/7217, 7201, 7219/02 and 7220 implantable arrhythmia management devices.
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