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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 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 NumberS005
Date Received08/21/2006
Decision Date10/03/2006
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 adapter cable, 1739-w, to allow the therapy dual 8 catheter to be used with the biosense webster stockert 70 rf generator, approved under p990071.
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