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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 COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP060019
Supplement NumberS004
Date Received04/14/2008
Decision Date06/13/2008
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extension of ablation time from 60 to 120 seconds for the cool path catheters, and modifications to the labeling and user interface to accomplish this.
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