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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 2DR/VR AICD SYSTEMS & MODEL 2844, VERSION 3.1 SOFTWARE
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS015
Date Received06/08/2000
Decision Date08/04/2000
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pulse generator models 1860 and 1861, pulse generator software version 1. 3, and program/recorder/monitor software model 2844, version 3. 1.
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