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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 NameENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantMEDTRONIC, INC.
PMA NumberP980016
Supplement NumberS413
Date Received04/18/2013
Decision Date06/11/2013
Product Code
LWS[ Registered Establishments with LWS ]
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 enhancements to model 9986 desktop/boss for use on the model 2090 medtronic carelink programmer for the devices.
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