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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 7223CX MICRO JEWEL II(TM)
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS024
Date Received04/24/1996
Decision Date11/08/1996
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for medtronic model 7218 b/c/d/e with the model 9896 software and the medtronic model 7223 cx micro jewell ii with model 5705 active can emulator and model 9955 software.
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