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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.
 
DeviceBOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP920047
Supplement NumberS035
Date Received08/21/2006
Decision Date12/01/2006
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A CHOKE IN THE XP APM WHICH WILL ELIMINATE THE DELIVERY OF THE RF ENERGY WHERE THE USER FAILED TO CONNECT OR IMPROPERLY CONNECTED THE DISPERSIVE INDIFFERENT PATCH (DIP) ELECTRODES TO THE PATIENT.
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