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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 DUAL 8 ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameelectrophysiology ablation catheter
ApplicantIRVINE BIOMEDICAL,INC.(IBI)
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 - other
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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