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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 ACID FAMILY SYSTEMS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantGUIDANT CORP.
PMA NumberP910077
Supplement NumberS025
Date Received09/10/1998
Decision Date12/02/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ventak(r) mini(tm) iv models 1790, 1792, 1793, and 1796; ventak(r) mini(tm) iii+he models 1788 and 1789; ventak(r) mini(tm) application software model 2840 (version 4. 0); and the sensitivity adjustment for ventak(r) mini(tm) and mini(tm) ii icd systems.
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