Gen V CryoConsole RoHS Compliant

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Premarket Approval P100010 S076

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 catheter recognition files to be downloaded to the cryoconsole for recognition of two new cryoablation catheters, arctic front advance pro models afapro23 and afapro28.

DeviceGen V CryoConsole RoHS Compliant
Classification NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic CryoCath LP
Date Received2018-03-05
Decision Date2018-05-04
PMAP100010
SupplementS076
Product CodeOAE
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
S135 2022-12-22 30-day Notice
S134 2022-12-21 30-day Notice
S133 2022-11-14 30-day Notice
S132 2022-10-28 30-day Notice
S131
S130 2022-08-24 30-day Notice
S129 2022-07-25 30-day Notice
S128 2022-05-20 30-day Notice
S127 2022-04-25 30-day Notice
S126 2022-02-16 30-day Notice
S125 2022-02-14 30-day Notice
S124 2021-12-21 30-day Notice
S123
S122 2021-11-18 30-day Notice
S121 2021-11-08 30-day Notice
S120 2021-10-12 30-day Notice
S119 2021-08-09 Real-time Process
S118
S117 2021-07-09 Normal 180 Day Track No User Fee
S116 2021-07-08 Normal 180 Day Track No User Fee
S115 2021-05-04 30-day Notice
S114
S113 2021-02-03 30-day Notice
S112 2020-11-24 30-day Notice
S111 2020-11-19 30-day Notice
S110
S109 2020-10-21 30-day Notice
S108
S107 2020-06-29 Real-time Process
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

Device IDPMASupp
00613994804273 P100010 000
00643169007574 P100010 004
00643169007581 P100010 004
00643169073258 P100010 004
00643169073265 P100010 004
00643169023482 P100010 008
00643169023475 P100010 008
00643169023239 P100010 008
00643169105515 P100010 015
00643169105539 P100010 015
00643169753686 P100010 015
00643169753693 P100010 015
00643169345591 P100010 030
00643169345614 P100010 030
00643169450387 P100010 037
00643169450370 P100010 037
00643169504783 P100010 043
00643169504837 P100010 043
00643169504899 P100010 043
00643169504905 P100010 043
00643169495814 P100010 047
00643169577732 P100010 048
00643169577749 P100010 048
00763000279783 P100010 062
00643169939271 P100010 066
00643169939318 P100010 066
00643169889903 P100010 070
00643169889880 P100010 070
00643169976368 P100010 084
00643169976382 P100010 084
00763000088637 P100010 084
00763000197766 P100010 084
00763000245412 P100010 093
00763000245436 P100010 093
00643169878327 P100010 094
00643169878365 P100010 094
00763000245481 P100010 098
00763000245474 P100010 098
00763000341473 P100010 103
00763000341480 P100010 103
00763000431488 P100010 114
00763000431501 P100010 114
00763000431457 P100010 114
00763000431464 P100010 114
00763000341497 P100010 116
00763000341503 P100010 116
00763000707781 P100010 116
00763000707774 P100010 116
00763000431532 P100010 119
00763000431518 P100010 119
00763000655143 P100010 123
00763000655136 P100010 123

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