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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 AV DDD/AV II DDDD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter pulse generator and program software
ApplicantGUIDANT CORP.
PMA NumberP960040
Supplement NumberS017
Date Received07/25/2000
Decision Date12/13/2000
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ventak(r) av ddd/ av ii ddd model 2833 version 4. 0 software, the ventak(r) vr model 2841 version 4. 0 software and the delta(r)/ vista(r) model 2881 version 2. 0 software.
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