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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 ABLATION CATHETER
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 NumberS020
Date Received11/16/2010
Decision Date01/11/2011
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design modification to the tip electrode stem outer diameter (od) so that the gap between the tip electrode od and tube inside diameter (id) is reduced to -0. 0015¿ to +0. 0015¿ from -0. 003¿ to +0. 003¿ for consistent gap interference.
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