Artic Front Advance Pro Cardiac Cryoablation Catheter

FDA Premarket Approval P100010 S105

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 an alternate supplier, medtronic puerto rico operations co. , villalba, for the manufacture of the arctic front advance pro guidewire lumen (gwl) subassembly

DeviceArtic Front Advance Pro Cardiac Cryoablation Catheter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic CryoCath LP
Date Received2020-05-20
Decision Date2020-06-18
PMAP100010
SupplementS105
Product CodeOAE 
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 ms Mvs46 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P100010Original Filing
S106 2020-06-12 30-day Notice
S105 2020-05-20 30-day Notice
S104 2020-05-14 30-day Notice
S103 2020-02-18 30-day Notice
S102 2020-02-18 30-day Notice
S101 2020-01-27 30-day Notice
S100 2019-12-23 30-day Notice
S099 2019-11-15 30-day Notice
S098
S097 2019-09-20 30-day Notice
S096 2019-09-12 30-day Notice
S095 2019-06-10 30-day Notice
S094 2019-05-16 Normal 180 Day Track No User Fee
S093 2019-05-09 Real-time Process
S092 2019-05-07 30-day Notice
S091 2019-04-30 30-day Notice
S090
S089 2019-03-11 30-day Notice
S088 2019-01-30 30-day Notice
S087 2018-12-06 30-day Notice
S086 2018-11-02 Normal 180 Day Track No User Fee
S085 2018-09-17 30-day Notice
S084 2018-09-17 Normal 180 Day Track
S083 2018-08-28 30-day Notice
S082 2018-08-27 30-day Notice
S081 2018-07-09 30-day Notice
S080 2018-06-28 30-day Notice
S079 2018-06-15 30-day Notice
S078 2018-03-28 30-day Notice
S077 2018-03-27 30-day Notice
S076 2018-03-05 Real-time Process
S075 2018-02-16 30-day Notice
S074 2018-02-08 30-day Notice
S073 2018-02-07 Real-time Process
S072 2018-01-16 30-day Notice
S071 2017-12-11 Real-time Process
S070 2017-11-20 Normal 180 Day Track
S069 2017-11-17 30-day Notice
S068 2017-11-01 30-day Notice
S067 2017-07-26 30-day Notice
S066 2017-07-13 Real-time Process
S065 2017-07-11 Real-time Process
S064 2017-03-28 30-day Notice
S063 2017-03-21 30-day Notice
S062 2017-02-23 30-day Notice
S061 2016-12-07 30-day Notice
S060 2016-11-14 Real-time Process
S059 2016-10-24 30-day Notice
S058 2016-07-08 Normal 180 Day Track No User Fee
S057 2016-06-07 30-day Notice
S056 2016-06-07 Real-time Process
S055
S054 2016-04-01 Real-time Process
S053 2016-02-10 Real-time Process
S052 2015-12-18 30-day Notice
S051 2015-10-09 30-day Notice
S050 2015-07-28 Special (immediate Track)
S049
S048 2015-03-16 Real-time Process
S047 2015-01-29 Real-time Process
S046 2014-12-08 Normal 180 Day Track
S045 2014-09-15 30-day Notice
S044 2014-09-02 30-day Notice
S043 2014-08-29 30-day Notice
S042 2014-08-05 30-day Notice
S041 2014-07-23 30-day Notice
S040 2014-06-27 30-day Notice
S039 2014-06-23 Real-time Process
S038 2014-06-23 30-day Notice
S037 2014-06-23 Real-time Process
S036 2014-06-03 30-day Notice
S035 2014-03-05 30-day Notice
S034 2014-01-15 30-day Notice
S033 2014-01-09 30-day Notice
S032 2013-10-16 Normal 180 Day Track No User Fee
S031 2013-09-11 135 Review Track For 30-day Notice
S030 2013-06-17 Real-time Process
S029 2013-06-04 Real-time Process
S028 2013-05-13 30-day Notice
S027 2013-05-03 30-day Notice
S026 2013-05-03 135 Review Track For 30-day Notice
S025 2013-04-26 135 Review Track For 30-day Notice
S024 2013-04-18 Real-time Process
S023 2013-02-22 30-day Notice
S022 2013-03-05 Real-time Process
S021 2012-10-22 30-day Notice
S020 2012-10-01 30-day Notice
S019 2012-09-13 30-day Notice
S018 2012-07-26 Normal 180 Day Track
S017 2012-06-26 Real-time Process
S016 2012-03-06 30-day Notice
S015 2012-02-17 Real-time Process
S014 2012-01-17 30-day Notice
S013 2011-12-16 30-day Notice
S012 2011-09-07 30-day Notice
S011 2011-08-18 30-day Notice
S010 2011-04-29 Real-time Process
S009 2011-03-30 30-day Notice
S008 2011-03-25 Real-time Process
S007 2011-02-15 Real-time Process
S006
S005 2011-02-11 Real-time Process
S004 2011-02-07 Real-time Process
S003 2011-02-03 30-day Notice
S002 2011-02-01 Real-time Process
S001 2011-01-12 Normal 180 Day Track No User Fee

NIH GUDID Devices

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