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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.
 
DeviceTHERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
IRVINE BIOMEDICAL,INC.(IBI)
2375 morse ave.
irvine, CA 92614
PMA NumberP040042
Supplement NumberS016
Date Received07/30/2009
Decision Date08/28/2009
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the proximal component of the ablation catheters.
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