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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 MINI AICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS008
Date Received06/13/1995
Decision Date12/21/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
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 mini aicd system, which includes:model numbers 1645, 1740, 1741, 1745, and 1746 pulse generators; model 2840 software application; model 2909 multiple application utility (mau); and model 6996 df-1 plug.
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