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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) P3 AICD(TM) SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP930035
Supplement NumberS001
Date Received11/10/1994
Decision Date09/08/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ventak p3 w/ventak software module, endotak c lead, endotak sq patch lead, endotak sq lead array, aicd y connector, epicardial patch lead; software module model 2836 revision 2. 1 software; and alternate sterilization process.
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