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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 PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS015
Date Received05/10/1996
Decision Date05/15/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the ventak prx aicd (models 1700 and 1705), ventak prx ii aicd model 1715, ventak prx iii aicd (models 1720 and 1725), ventak mini aicd (models 1645, 1740, 1741, 1745, and 1746), ventak mini hc aicd (models 1742, 1743 and 1640), and ventak mini aicd (models 1652, 1662, 1752, 1762, 1753, and 1763) which requested approval to add a patient group to the indications for use.
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