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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 NameIBI CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP040014
Supplement NumberS001
Date Received04/06/2005
Decision Date01/20/2006
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 the ibi therapy ablation catheter (4 mm tip) to be used with the 1711-m cable which connects the ibi therapy ablation catheter to the medtronic cardio rhythm atakr generator as well as for the ibi therapy ablation catheter (4 mm tip) to be used with the 1713-w cable which connects the ibi therapy ablation catheter to the biosense webster stockert 70 rf generator.
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