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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.
 
DeviceIBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Applicant
IRVINE BIOMEDICAL, INC.
2375 morse ave.
irvine, CA 92614
PMA NumberP040014
Date Received03/15/2004
Decision Date01/14/2005
Product Code
LPB[ Registered Establishments with LPB ]
Docket Number 05M-0088
Notice Date 03/09/2005
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 
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