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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 Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP020025
Supplement NumberS014
Date Received09/22/2005
Decision Date12/23/2005
Product Code
OAD
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
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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