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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 & IBI-1500T9 RF ABLATION GENERATOR
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP060019
Supplement NumberS005
Date Received07/14/2008
Decision Date06/12/2009
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the cool point pump and tubing set to provide irrigation of the therapy cool path ablation catheter as well as modification to the ibi 1500t9 rf ablation generator to function with the cool point pump. The device, as modified, will be marketed under the trade name ibi-1500t9-cp rf ablation generator.
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