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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 THERAPY ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP040014
Supplement NumberS002
Date Received11/09/2005
Decision Date12/08/2005
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the tube fusing process and a change in the adhesive used in the weld joint process.
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