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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceIBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
Generic NameCardiac ablation percutaneous catheter
ApplicantIRVINE BIOMEDICAL, INC.
2375 MORSE AVE.
IRVINE, CA 92614
PMA NumberP040014
Date Received03/15/2004
Decision Date01/14/2005
Product Code LPB 
Docket Number 05M-0088
Notice Date 03/09/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE IBI THERAPY CARDIAC ABLATION SYSTEM. THE DEVICE IS INDICATED FOR MAPPING AND FOR USE WITH A COMPATIBLE RF GENERATOR FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S017 S018  S016 S019 S023 S027 S028 S004 S007 S002 S001 
S032 S020 S021 S024 S026 S025 S022 S003 S011 S013 S008 S009 
S015 S005 S006 S010 S012 S029 S030 S031 S034 S038 S039 S036 
S035 S046 S047 S045 S037 S041 S040 S048 S042 S043 S044 
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