|Trade Name||VENTAK(R) PRX (TM) II AICD SYSTEM|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Applicant||CARDIAC PACEMAKERS, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| 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.