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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 NameMODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS022
Date Received05/23/2001
Decision Date06/13/2001
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 2725 ventak(r) prizm(tm) diagnostic/restoration tool version 1. 5. The device is indicated to diagnose and restore to factory normal settings ventak prizm/prizm he devices that have been affected by a specific memory interation that results in safety mode.
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