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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 NameBLAZER RPM CARDIAC ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Nameelectrode,percutaneous,conduction tissue ablation
ApplicantEP TECHNOLOGIES, INC.
PMA NumberP920047
Supplement NumberS018
Date Received08/28/2002
Decision Date02/12/2003
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the blazer rpm catheter which featured minor design changes (e. G. , addition of three transducer rings, laser welded center support and multiple coaxial design) to the blazer ii catheter.
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