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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 AICD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP960040
Supplement NumberS012
Date Received08/23/1999
Decision Date01/21/2000
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval is for modifications to ventak dr/vr aicd. The device, as modified, will be marketed under the tradename ventak prizm dr/vr aicd system, models 1850, 1851, 1855 and 1856 with model 2844 software, version 1. 1 and the indications remains the same as in the original pma.
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