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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 NameTHERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP040014
Supplement NumberS003
Date Received06/13/2006
Decision Date11/13/2006
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for bi-directional functionality design modifications to the therapy ablation catheter.
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