MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System

FDA Premarket Approval P100009 S037

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

A modification to the bonding process of the radiopaque ring and delivery catheter shaft of the mitraclip ntr/xtr and g4 clip delivery systems

DeviceMitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System
Generic NameMitral Valve Repair Devices
ApplicantABBOTT VASCULAR INC.
Date Received2020-01-31
Decision Date2020-02-26
PMAP100009
SupplementS037
Product CodeNKM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P100009Original Filing
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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