Therapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter

FDA Premarket Approval P040042 S044

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

To add a second sterilization cycle for previously sterilized product

DeviceTherapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantIRVINE BIOMEDICAL,INC.(IBI)
Date Received2020-02-04
Decision Date2020-03-04
PMAP040042
SupplementS044
Product CodeOAD 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address IRVINE BIOMEDICAL,INC.(IBI) 2375 Morse Ave. irvine, CA 92614

Supplemental Filings

Supplement NumberDateSupplement Type
P040042Original Filing
S044 2020-02-04 30-day Notice
S043 2019-07-29 30-day Notice
S042 2019-03-15 30-day Notice
S041 2018-12-12 Special (immediate Track)
S040 2018-02-05 30-day Notice
S039
S038
S037 2017-05-04 30-day Notice
S036 2016-08-12 30-day Notice
S035 2016-05-27 30-day Notice
S034 2016-02-19 30-day Notice
S033 2015-11-20 Real-time Process
S032 2015-09-23 30-day Notice
S031 2015-08-21 Normal 180 Day Track No User Fee
S030 2015-04-20 30-day Notice
S029 2014-11-07 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 2013-08-30 30-day Notice
S024 2011-11-29 135 Review Track For 30-day Notice
S023 2011-10-14 30-day Notice
S022 2011-05-09 30-day Notice
S021 2011-01-18 30-day Notice
S020 2010-11-16 Real-time Process
S019
S018 2010-02-22 30-day Notice
S017 2009-12-14 30-day Notice
S016 2009-07-30 30-day Notice
S015 2009-05-04 30-day Notice
S014 2008-11-10 30-day Notice
S013 2008-09-04 Normal 180 Day Track
S012 2008-05-14 30-day Notice
S011 2007-09-19 30-day Notice
S010 2007-03-16 30-day Notice
S009 2007-03-12 Normal 180 Day Track
S008 2007-02-12 Real-time Process
S007 2006-12-18 135 Review Track For 30-day Notice
S006 2006-09-05 Normal 180 Day Track
S005 2006-08-18 Real-time Process
S004 2006-08-01 Real-time Process
S003 2006-06-02 Real-time Process
S002 2006-05-01 Real-time Process
S001 2005-11-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05414734306980 P040042 000
05414734306973 P040042 000
05414734306997 P040042 000
05414734307000 P040042 000
05414734307024 P040042 000
05414734307017 P040042 000
05414734308939 P040042 005
05414734309073 P040042 006
05414734307550 P040042 006
05414734307567 P040042 006
05414734307581 P040042 006
05414734307598 P040042 006
05414734300162 P040042 009
05414734300179 P040042 009
05414734300186 P040042 009
05414734300193 P040042 009
05414734300247 P040042 009
05414734300254 P040042 009
05414734300261 P040042 009
05414734300278 P040042 009
05414734300155 P040042 009

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