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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(R) P MODEL 1600
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP890061
Supplement NumberS012
Date Received10/16/1996
Decision Date11/12/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate sterilization facility located at cosmed of illinois, 1160 northpoint blvd. , waukegan, il 60085 - this supplement reviewed under the supplement pilot program - this approval applies only to the new sterilization site request.
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