Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Premarket Approval P060019

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.

Pre-market Approval Supplement Details

Approval for the therapy cool path ablation catheter and ibi 1500t9 rf ablation generator. The therapy cool path ablation catheter is intended for use with a compatible external infusion pump and the ibi 1500t9 radiofrequency (rf) generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. The ibi 1500t9 rf ablation generator is intended for use with compatible st. Jude medical temperature controlled ablation catheters for creating endocardial lesions to treat cardiac arrhythmias (i. E. Supraventricular tachycardias, and atrial flutter). The generator is internally limited to 50 watts when used with the therapy cool path catheters. A compatible external infusion pump must be connected when used with therapy cool path catheters.

Classification NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Date Received2006-05-30
Decision Date2007-03-16
Notice Date2007-03-26
Product CodeOAD
Docket Number07M-0108
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address IRVINE BIOMEDICAL, INC. 2375 Morse Ave. irvine, CA 92614
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P060019Original Filing
S054 2021-09-14 30-day Notice
S053 2021-04-19 30-day Notice
S052 2021-04-13 30-day Notice
S051 2021-02-25 30-day Notice
S050 2021-01-13 Real-time Process
S049 2020-09-18 30-day Notice
S047 2020-02-20 Real-time Process
S046 2020-02-04 30-day Notice
S045 2019-03-15 30-day Notice
S044 2018-12-12 Special (immediate Track)
S042 2018-02-05 30-day Notice
S041 2017-09-11 Real-time Process
S039 2017-05-04 30-day Notice
S038 2016-08-12 30-day Notice
S037 2016-05-27 30-day Notice
S036 2016-02-19 30-day Notice
S035 2015-11-20 Real-time Process
S034 2015-09-23 30-day Notice
S033 2015-08-21 Normal 180 Day Track No User Fee
S032 2015-05-15 Normal 180 Day Track No User Fee
S031 2015-04-20 30-day Notice
S030 2014-11-07 Real-time Process
S029 2014-09-09 Real-time Process
S028 2014-04-30 Normal 180 Day Track No User Fee
S027 2014-03-03 Real-time Process
S026 2013-11-27 Normal 180 Day Track
S025 2013-09-25 Normal 180 Day Track
S024 2013-08-30 30-day Notice
S023 2012-07-11 135 Review Track For 30-day Notice
S022 2012-07-10 Real-time Process
S021 2012-05-11 Real-time Process
S020 2011-11-29 135 Review Track For 30-day Notice
S019 2011-10-14 30-day Notice
S017 2011-01-18 30-day Notice
S016 2010-11-30 30-day Notice
S015 2010-11-16 Real-time Process
S014 2010-09-29 30-day Notice
S013 2010-08-30 Normal 180 Day Track
S011 2010-02-22 30-day Notice
S010 2009-12-14 30-day Notice
S009 2009-05-14 Normal 180 Day Track
S008 2009-05-04 30-day Notice
S007 2008-11-10 30-day Notice
S005 2008-07-14 Normal 180 Day Track
S004 2008-04-14 Real-time Process
S003 2007-06-07 Real-time Process
S002 2007-05-31 Real-time Process
S001 2007-03-30 135 Review Track For 30-day Notice


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