Freezor, Arctic Front Advance (AFA) CryoAblation Catheters

FDA Premarket Approval P020045 S093

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

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DeviceFreezor, Arctic Front Advance (AFA) CryoAblation Catheters
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantMedtronic CryoCath LP
Date Received2020-01-27
Decision Date2020-02-03
PMAP020045
SupplementS093
Product CodeLPB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic CryoCath LP 8200 Coral Sea Street mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P020045Original Filing
S093 2020-01-27 30-day Notice
S092
S091
S090 2019-09-13 30-day Notice
S089 2018-07-17 30-day Notice
S088 2018-06-15 30-day Notice
S087 2018-03-05 Real-time Process
S086 2018-02-07 Real-time Process
S085 2018-01-16 30-day Notice
S084 2017-11-01 30-day Notice
S083 2017-07-11 Real-time Process
S082 2017-03-21 30-day Notice
S081 2017-02-23 30-day Notice
S080 2017-02-21 30-day Notice
S079
S078 2016-11-14 Real-time Process
S077 2016-10-24 30-day Notice
S076 2016-06-07 30-day Notice
S075 2016-06-07 Real-time Process
S074 2016-02-10 Real-time Process
S073 2016-01-28 Panel Track
S072 2015-12-28 30-day Notice
S071 2015-12-28 30-day Notice
S070 2015-12-18 30-day Notice
S069 2015-12-11 Special (immediate Track)
S068 2015-10-09 30-day Notice
S067 2015-07-21 Real-time Process
S066 2015-03-16 Real-time Process
S065 2015-01-29 Real-time Process
S064 2014-10-16 Normal 180 Day Track
S063 2014-09-15 30-day Notice
S062 2014-09-02 30-day Notice
S061 2014-08-29 30-day Notice
S060 2014-08-11 Real-time Process
S059 2014-07-31 Real-time Process
S058 2014-06-27 30-day Notice
S057 2014-06-23 Real-time Process
S056 2014-06-23 30-day Notice
S055 2014-06-23 Real-time Process
S054 2014-06-03 Real-time Process
S053 2014-04-22 30-day Notice
S052 2014-01-15 30-day Notice
S051 2014-01-09 30-day Notice
S050 2013-07-29 Normal 180 Day Track No User Fee
S049 2013-06-04 Real-time Process
S048 2013-05-24 30-day Notice
S047 2013-05-03 30-day Notice
S046 2013-02-15 Normal 180 Day Track No User Fee
S045 2012-07-26 Real-time Process
S044 2012-06-26 Real-time Process
S043 2012-05-16 30-day Notice
S042 2012-02-23 Real-time Process
S041 2011-12-16 30-day Notice
S040 2011-09-07 30-day Notice
S039 2011-08-18 30-day Notice
S038 2011-03-30 30-day Notice
S037 2011-03-25 Real-time Process
S036 2011-02-15 30-day Notice
S035 2010-10-20 Real-time Process
S034 2010-08-20 30-day Notice
S033
S032
S031
S030
S029 2010-03-15 Normal 180 Day Track No User Fee
S028 2010-03-08 135 Review Track For 30-day Notice
S027 2009-03-17 30-day Notice
S026 2009-03-09 Normal 180 Day Track
S025 2008-08-19 Special (immediate Track)
S024
S023
S022 2007-05-31 30-day Notice
S021 2007-01-09 Real-time Process
S020
S019 2006-05-16 30-day Notice
S018
S017 2006-03-14 30-day Notice
S016 2006-03-15 Real-time Process
S015 2006-02-15 135 Review Track For 30-day Notice
S014 2005-12-20 Real-time Process
S013
S012 2005-10-13 Special (immediate Track)
S011 2005-07-21 Special (immediate Track)
S010 2005-06-16 Real-time Process
S009 2005-06-09 Special (immediate Track)
S008 2005-06-06 Special (immediate Track)
S007 2005-02-14 Real-time Process
S006 2004-05-10 Real-time Process
S005 2004-05-10 Real-time Process
S004 2004-03-22 Real-time Process
S003 2003-12-29 Real-time Process
S002 2003-09-15 Real-time Process
S001 2003-06-05 Normal 180 Day Track No User Fee

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