TactiCath Contact Force Ablation Catheter Sensor Enabled

FDA Premarket Approval P130026 S075

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

The addition of a sterilization chamber (chamber 5) at the steris sterilization facility in costa rica

DeviceTactiCath Contact Force Ablation Catheter Sensor Enabled
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantSt. Jude Medical
Date Received2021-08-24
Decision Date2021-09-22
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical one St. Jude Medical Drive st. Paul, MN 55117

Supplemental Filings

Supplement NumberDateSupplement Type
P130026Original Filing
S076 2021-09-14 30-day Notice
S075 2021-08-24 30-day Notice
S074 2021-05-26 30-day Notice
S073 2021-05-05 30-day Notice
S071 2021-04-19 30-day Notice
S068 2021-01-13 Real-time Process
S067 2020-11-27 30-day Notice
S065 2020-09-18 30-day Notice
S064 2020-08-03 30-day Notice
S061 2020-05-06 30-day Notice
S060 2020-04-29 30-day Notice
S059 2020-03-19 30-day Notice
S057 2020-03-10 30-day Notice
S056 2020-03-10 30-day Notice
S055 2019-12-16 30-day Notice
S054 2019-11-20 30-day Notice
S053 2019-09-27 Special (immediate Track)
S052 2019-09-26 30-day Notice
S051 2019-09-12 Special (immediate Track)
S050 2019-08-20 30-day Notice
S049 2019-06-27 Special (immediate Track)
S047 2019-05-22 30-day Notice
S046 2019-05-10 Real-time Process
S045 2019-04-26 30-day Notice
S044 2019-03-25 30-day Notice
S043 2019-03-12 Special (immediate Track)
S042 2019-02-14 Normal 180 Day Track No User Fee
S041 2019-02-08 30-day Notice
S040 2019-02-08 30-day Notice
S039 2019-01-18 Special (immediate Track)
S038 2019-01-15 Normal 180 Day Track No User Fee
S037 2018-12-12 Special (immediate Track)
S036 2018-09-27 Normal 180 Day Track
S035 2018-07-05 Special (immediate Track)
S034 2018-07-02 Normal 180 Day Track
S033 2018-03-07 30-day Notice
S032 2018-02-21 Real-time Process
S031 2018-02-12 30-day Notice
S030 2018-02-06 30-day Notice
S029 2018-02-05 30-day Notice
S028 2017-12-15 135 Review Track For 30-day Notice
S027 2017-10-31 30-day Notice
S026 2017-07-21 Real-time Process
S023 2017-04-05 30-day Notice
S022 2016-08-12 30-day Notice
S021 2016-07-07 30-day Notice
S020 2016-05-11 30-day Notice
S019 2016-03-14 30-day Notice
S018 2016-03-07 30-day Notice
S017 2016-02-22 Real-time Process
S016 2016-02-19 30-day Notice
S015 2016-01-21 Special (immediate Track)
S014 2016-01-07 30-day Notice
S013 2015-12-07 Special (immediate Track)
S012 2015-11-20 Real-time Process
S011 2015-10-30 Normal 180 Day Track No User Fee
S010 2015-09-23 30-day Notice
S009 2015-08-27 Real-time Process
S008 2015-08-05 Real-time Process
S006 2015-07-02 Real-time Process
S005 2015-07-01 Real-time Process
S004 2015-04-14 Special (immediate Track)
S003 2015-03-27 Real-time Process
S002 2015-02-27 Special (immediate Track)
S001 2015-01-28 30-day Notice

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