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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 NameSAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantIRVINE BIOMEDICAL, INC.
PMA NumberP060019
Supplement NumberS009
Date Received05/14/2009
Decision Date02/23/2011
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 add bi-directional steering to the therapy cool path ablation catheter. The devices, as modified, will be marketed under the trade names safire blu irrigated ablation catheter and therapy cool path ablation catheter.
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