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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
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS010
Date Received06/26/1995
Decision Date02/05/1996
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR AICD MODELS:1705, PRX II MODEL 1715, AND PRX III MODELS 1720/1725, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
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