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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 NameVENTAK PRIZM DR/VR HE AICD
Classification Nameprogrammer, pacemaker
Generic Nameimplantable cardioverter defibrillator
Regulation Number870.3700
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS014
Date Received06/05/2000
Decision Date07/13/2000
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the software that controls program/recorder/monitors models 2901 and 2910.
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