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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 NameIBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
ApplicantIRVINE BIOMEDICAL, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S015 S016 S017 S018 S019 
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