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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) PRX (TM) II AICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP910077
Supplement NumberS007
Date Received04/06/1995
Decision Date11/20/1995
Product Code
LWS
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate manufacturing site for assembly of the external products (programmers, software modules/disks, external cardioverter defibrillators, and related accessories) which are used with dpi pacemaker and aicd systems. The proposed alternate manufacturing site (cardigan facility) is located at the following address: cpi cardigan facility, 599 cardigan road, shoreview, minnesota 55126.
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