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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 NumberS011
Date Received06/26/1995
Decision Date02/20/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacing the current connector top material for the above aicd model, pellethane 2363-75d polyurethane, with tecothane tt1075d-m polyurethane.
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