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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 NameEPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Nameelectrode,percutaneous,conduction tissue ablation
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP920047
Supplement NumberS030
Date Received09/22/2005
Decision Date12/23/2005
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at plexus electronic assembly, buffalo grove, illinois.
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