TactiCath Contact Force Ablation Catheter, Sensor Enabled

FDA Premarket Approval P130026 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

The modification of proximal cable leakage current in-process controls for the tacticath contact force ablation catheter, sensor enabled™ (tacticath se)

DeviceTactiCath Contact Force Ablation Catheter, Sensor Enabled
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantSt. Jude Medical
Date Received2020-08-03
Decision Date2020-08-25
PMAP130026
SupplementS064
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
S064 2020-08-03 30-day Notice
S063
S062
S061 2020-05-06 30-day Notice
S060 2020-04-29 30-day Notice
S059 2020-03-19 30-day Notice
S058
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)
S048
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
S025
S024
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
S007
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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