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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVENTAK(R) PRX (TM) II AICD SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910077
Supplement NumberS007
Date Received04/06/1995
Decision Date11/20/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
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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