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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.
 
DeviceIBI THERAPY DUAL 8 ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
IRVINE BIOMEDICAL,INC.(IBI)
2375 morse ave.
irvine, CA 92614
PMA NumberP040042
Supplement NumberS010
Date Received03/16/2007
Decision Date04/13/2007
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to add a new supplier for the isolation transformer for the 1500t6 (usa) rt generator.
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