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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 DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameelectrophysiology ablation catheter
ApplicantIRVINE BIOMEDICAL,INC.(IBI)
PMA NumberP040042
Supplement NumberS004
Date Received08/03/2006
Decision Date09/20/2006
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an extender module to the accessory list for the generator. The extender module will allow the user to place the generator up to an additional twenty feet from the patients.
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