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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 IMPLANTABLE CARIOVERTER DEFIBRILLATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS021
Date Received02/26/2001
Decision Date04/05/2001
Product Code
LWP[ Registered Establishments with LWP ]
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 ventak(r) prizm(tm) model 2844 software application, version 3. 3.
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