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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 2920 PRM SYSTEM ZOOM (VENTAK PRX AICD SYSTEM)
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameprogrammer recorder monitor (prm) for implantable pulse generators
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS031
Date Received12/20/1999
Decision Date05/18/2000
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 2920 zoom programming system.
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