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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 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namemplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP910077
Supplement NumberS027
Date Received02/17/1999
Decision Date03/17/1999
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design and manufacturing change to the pulse generator hybrid assembly for the ventak(r) mini iii(tm) and mini iv(tm) aicd(tm) systems (models 1782, 1783, 1786, 1788, 1789, 1790, 1792, 1793, and 1796).
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