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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 NameBOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T
Classification Namecardiac ablation percutaneous catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS035
Date Received08/22/2006
Decision Date12/01/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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