FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled

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

FDA Premarket Approval P110016 S064

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

Addition of a warning statement to the instructions for use regarding atrioesophageal fistulas

DeviceFlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled
Classification NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
ApplicantSt. Jude Medical, Inc. (Irvine Biomedical)
Date Received2019-09-12
Decision Date2019-10-09
PMAP110016
SupplementS064
Product CodeOAD
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical, Inc. (Irvine Biomedical) 2375 Morse Avenue irvine, CA 92614-6233

Supplemental Filings

Supplement NumberDateSupplement Type
P110016Original Filing
S081 2022-11-14 30-day Notice
S080
S079 2021-09-14 30-day Notice
S078 2021-08-24 30-day Notice
S077 2021-05-26 30-day Notice
S076 2021-04-19 30-day Notice
S075 2021-04-13 30-day Notice
S074 2021-02-25 30-day Notice
S073 2021-01-13 Real-time Process
S072 2020-10-28 Real-time Process
S071 2020-09-18 30-day Notice
S070
S069 2020-05-06 30-day Notice
S068 2020-03-19 30-day Notice
S067
S066 2020-02-04 30-day Notice
S065 2019-09-26 30-day Notice
S064 2019-09-12 Special (immediate Track)
S063 2019-06-24 Normal 180 Day Track No User Fee
S062 2019-04-26 30-day Notice
S061 2019-03-25 30-day Notice
S060 2019-03-15 30-day Notice
S059 2019-02-14 Normal 180 Day Track No User Fee
S058 2018-12-12 Special (immediate Track)
S057 2018-05-18 Special (immediate Track)
S056 2018-03-27 30-day Notice
S055 2018-02-14 30-day Notice
S054 2018-02-12 30-day Notice
S053 2018-02-05 30-day Notice
S052 2017-11-28 30-day Notice
S051 2017-11-02 30-day Notice
S050 2017-10-27 135 Review Track For 30-day Notice
S049 2017-08-22 30-day Notice
S048
S047 2017-06-30 30-day Notice
S046 2017-05-04 30-day Notice
S045 2017-04-28 30-day Notice
S044 2017-05-01 30-day Notice
S043 2017-04-28 30-day Notice
S042
S041 2017-03-28 30-day Notice
S040 2017-03-20 30-day Notice
S039 2017-03-13 30-day Notice
S038 2017-03-03 30-day Notice
S037
S036 2016-09-08 Special (immediate Track)
S035 2016-08-12 30-day Notice
S034 2016-06-24 135 Review Track For 30-day Notice
S033 2016-05-27 30-day Notice
S032 2016-05-27 30-day Notice
S031 2016-03-17 30-day Notice
S030 2016-03-14 30-day Notice
S029 2016-02-19 30-day Notice
S028 2015-11-25 30-day Notice
S027 2015-11-20 Real-time Process
S026 2015-11-12 Special (immediate Track)
S025 2015-11-05 Normal 180 Day Track
S024 2015-10-30 Normal 180 Day Track No User Fee
S023 2015-09-23 30-day Notice
S022 2015-09-01 30-day Notice
S021 2015-08-21 Normal 180 Day Track No User Fee
S020 2015-08-20 30-day Notice
S019
S018 2015-06-29 Special (immediate Track)
S017 2015-04-20 30-day Notice
S016 2015-02-05 Normal 180 Day Track No User Fee
S015 2015-02-04 Special (immediate Track)
S014 2014-11-07 Real-time Process
S013 2014-06-19 Normal 180 Day Track
S012 2014-04-30 Normal 180 Day Track No User Fee
S011 2014-03-03 Real-time Process
S010 2013-11-27 Normal 180 Day Track
S009 2013-08-30 30-day Notice
S008 2013-04-01 Panel Track
S007 2013-03-07 Normal 180 Day Track
S006 2013-01-24 Real-time Process
S005 2012-07-11 135 Review Track For 30-day Notice
S004 2012-07-10 Real-time Process
S003 2012-06-25 Normal 180 Day Track
S002 2012-05-11 Real-time Process
S001 2012-03-29 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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05414734311892 P110016 002
05414734311908 P110016 002
05414734311922 P110016 002
05415067002440 P110016 003
05415067002433 P110016 003
05415067002426 P110016 003
05415067002419 P110016 003
05415067002402 P110016 003
05415067002396 P110016 003
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05415067002372 P110016 003
05415067004574 P110016 006
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05415067004994 P110016 010
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05415067011510 P110016 013
05415067011503 P110016 013
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05415067011152 P110016 013
05415067011145 P110016 013
05415067011138 P110016 013
05415067011107 P110016 013
05415067011114 P110016 013
05415067020093 P110016 025
05415067020086 P110016 025
05415067020079 P110016 025
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05415067020055 P110016 025
05415067020048 P110016 025
05415067020031 P110016 025
05415067020024 P110016 025
05415067024916 P110016 025

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