FREEZOR CARDIAC CRYOABLATION CATHETER, ETRA SURGICAL CARDIAC CRYOABLATION DEVICE, MAX SURGICAL CARDIAC CRYOABLATION DEVI

Cardiac Ablation Percutaneous Catheter

FDA Premarket Approval P020045 S052

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

Two additional sterilization chambers in the sterigenics eo facility in toronto, canada.

DeviceFREEZOR CARDIAC CRYOABLATION CATHETER, ETRA SURGICAL CARDIAC CRYOABLATION DEVICE, MAX SURGICAL CARDIAC CRYOABLATION DEVI
Classification NameCardiac Ablation Percutaneous Catheter
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantMedtronic CryoCath LP
Date Received2014-01-15
Decision Date2014-02-07
PMAP020045
SupplementS052
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
S102 2022-12-22 30-day Notice
S101 2022-07-25 30-day Notice
S100 2022-02-16 30-day Notice
S099 2021-07-19 Real-time Process
S098
S097
S096 2021-05-03 30-day Notice
S095
S094 2021-02-23 30-day Notice
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

NIH GUDID Devices

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