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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTHERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameelectrophysiology ablation catheter
ApplicantIRVINE BIOMEDICAL,INC.(IBI)
PMA NumberP040042
Date Received10/04/2004
Decision Date11/18/2005
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 05M-0476
Notice Date 11/28/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the therapy dual 8 cardiac ablation system. The device is indicated for the treatment of typical atrial flutter.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S020 S021 S022 S023 S024 S025 S026 S027 
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