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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
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP060019
Supplement NumberS013
Date Received10/05/2010
Decision Date12/03/2010
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 to change the material of the extension tube to increase the torque resistance of the extension tube during handle manipulation. The material of the extension tube will be changed from a non-braided pellethane to a pebax braided tube (72d). Additionally, the length of the extension tube and the internal fluid lumen tube will be decreased from 11 cm to 4 cm.
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