IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR

Cardiac Ablation Percutaneous Catheter

FDA Premarket Approval P040014

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 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.

DeviceIBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
Classification NameCardiac Ablation Percutaneous Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantIRVINE BIOMEDICAL, INC.
Date Received2004-03-15
Decision Date2005-01-14
Notice Date2005-03-09
PMAP040014
SupplementS
Product CodeLPB
Docket Number05M-0088
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
P040014Original Filing
S047 2022-10-28 Normal 180 Day Track No User Fee
S046 2022-10-19 Normal 180 Day Track No User Fee
S045 2021-09-14 30-day Notice
S044 2021-04-13 30-day Notice
S043 2021-02-25 30-day Notice
S042 2021-01-13 Real-time Process
S041 2020-09-18 30-day Notice
S040
S039 2020-02-20 Real-time Process
S038 2020-02-04 30-day Notice
S037 2019-07-29 30-day Notice
S036 2019-03-15 30-day Notice
S035 2018-12-12 Special (immediate Track)
S034 2018-02-05 30-day Notice
S033
S032 2017-05-04 30-day Notice
S031 2016-08-12 30-day Notice
S030 2016-05-27 30-day Notice
S029 2016-02-19 30-day Notice
S028 2015-11-20 Real-time Process
S027 2015-09-23 30-day Notice
S026 2015-08-21 Normal 180 Day Track No User Fee
S025 2015-04-20 30-day Notice
S024 2014-11-07 Real-time Process
S023 2014-04-30 Normal 180 Day Track No User Fee
S022 2014-03-03 Real-time Process
S021 2013-11-27 Normal 180 Day Track
S020 2013-08-30 30-day Notice
S019 2011-11-29 135 Review Track For 30-day Notice
S018 2011-10-14 30-day Notice
S017 2011-05-09 30-day Notice
S016 2011-01-18 30-day Notice
S015 2010-11-16 Real-time Process
S014
S013 2010-02-22 30-day Notice
S012 2009-12-14 30-day Notice
S011 2009-07-30 30-day Notice
S010 2009-05-04 30-day Notice
S009 2008-11-10 30-day Notice
S008 2008-09-04 Normal 180 Day Track
S007 2008-05-14 30-day Notice
S006 2007-02-12 Real-time Process
S005 2006-12-18 135 Review Track For 30-day Notice
S004 2006-09-05 Normal 180 Day Track
S003 2006-06-12 Normal 180 Day Track
S002 2005-11-09 30-day Notice
S001 2005-04-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734309110 P040014 000
05414734306928 P040014 000
05414734306935 P040014 000
05414734306942 P040014 000
05414734306959 P040014 000
05414734306911 P040014 000
05414734308755 P040014 000
05414734308830 P040014 000
05414734308854 P040014 001
05414734308847 P040014 001
05414734308335 P040014 003
05414734308359 P040014 003
05414734308342 P040014 003
05414734308977 P040014 004
05414734308403 P040014 004
05414734308397 P040014 004
05414734308380 P040014 004

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.