MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System

Mitral Valve Repair Devices

FDA Premarket Approval P100009 S028

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 the mitraclip nt clip delivery system and mitraclip ntr/xtr clip delivery system for expanding the indication to include secondary mitral regurgitation. The devices, when used with maximally tolerated guideline-directed medical therapy (gdmt), are indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (mr; mr >= grade iii per american society of echocardiography criteria) in patients with a left ventricular ejection fraction (lvef) >= 20% and

DeviceMitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System
Classification NameMitral Valve Repair Devices
Generic NameMitral Valve Repair Devices
ApplicantABBOTT VASCULAR INC.
Date Received2018-11-06
Decision Date2019-03-14
PMAP100009
SupplementS028
Product CodeNKM
Advisory CommitteeCardiovascular
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100009Original Filing
S051 2023-01-03 30-day Notice
S050 2022-11-16 30-day Notice
S049 2022-11-09 30-day Notice
S048 2022-10-11 30-day Notice
S047 2022-08-25 30-day Notice
S046 2022-07-22 30-day Notice
S045 2022-01-31 Normal 180 Day Track No User Fee
S044 2021-09-22 30-day Notice
S043 2021-07-26 30-day Notice
S042 2021-03-31 Real-time Process
S041
S040
S039 2021-02-08 30-day Notice
S038 2021-01-25 30-day Notice
S037 2020-01-31 30-day Notice
S036 2019-09-03 30-day Notice
S035 2019-08-19 30-day Notice
S034 2019-08-06 Special (immediate Track)
S033 2019-06-28 Special (immediate Track)
S032 2019-06-24 30-day Notice
S031
S030 2019-05-03 Special (immediate Track)
S029
S028 2018-11-06 Panel Track
S027 2018-05-31 135 Review Track For 30-day Notice
S026 2018-05-15 Normal 180 Day Track No User Fee
S025 2017-10-24 Normal 180 Day Track
S024 2017-05-26 30-day Notice
S023 2017-04-03 30-day Notice
S022 2017-03-29 30-day Notice
S021 2016-06-15 135 Review Track For 30-day Notice
S020 2016-06-06 30-day Notice
S019 2016-05-26 30-day Notice
S018 2016-05-11 Real-time Process
S017 2016-03-01 Special (immediate Track)
S016 2015-11-18 Normal 180 Day Track No User Fee
S015 2015-10-01 Normal 180 Day Track
S014 2015-09-30 30-day Notice
S013 2015-09-15 30-day Notice
S012 2015-05-04 Real-time Process
S011 2015-04-08 30-day Notice
S010 2015-03-30 Normal 180 Day Track No User Fee
S009 2014-11-24 30-day Notice
S008 2014-11-19 30-day Notice
S007 2014-07-11 30-day Notice
S006 2014-06-16 30-day Notice
S005 2014-05-01 Special (immediate Track)
S004 2014-04-18 Real-time Process
S003
S002 2013-11-26 Normal 180 Day Track No User Fee
S001 2013-11-26 Normal 180 Day Track No User Fee

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