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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 P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP930035
Supplement NumberS005
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 p2 aicd model 1625 and the ventak pc aicd models 1630 and 1635 which requested approval to add a patient group to the indications for use.
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