Therapy Cool Path Ablation Catheter (including all braid catheter)

FDA Premarket Approval P060019 S047

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

Approval for a new pouch materials, pouch seal strength, and pouch sealer changes.

DeviceTherapy Cool Path Ablation Catheter (including all braid catheter)
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantIRVINE BIOMEDICAL, INC.
Date Received2020-02-20
Decision Date2020-04-24
PMAP060019
SupplementS047
Product CodeOAD 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address IRVINE BIOMEDICAL, INC. 2375 Morse Ave. irvine, CA 92614

Supplemental Filings

Supplement NumberDateSupplement Type
P060019Original Filing
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)
S043
S042 2018-02-05 30-day Notice
S041 2017-09-11 Real-time Process
S040
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
S018
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
S012
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
S006
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

NIH GUDID Devices

Device IDPMASupp
05414734309059 P060019 000
05414734308595 P060019 000
05414734308588 P060019 000
05414734308571 P060019 000
05414734308564 P060019 000
05414734306737 P060019 000
05414734306720 P060019 000
05414734306713 P060019 000
05414734306706 P060019 000
05415067019875 P060019 002
05414734309080 P060019 005
05414734258616 P060019 005
05415067008985 P060019 005
05414734310765 P060019 021
05414734310758 P060019 021
05414734310741 P060019 021
05414734310734 P060019 021
05414734310680 P060019 021
05414734310673 P060019 021
05414734310666 P060019 021
05414734310659 P060019 021

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