MitraClip NTR/XTR Delivery System

FDA Premarket Approval P100009 S042

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

Nitinol gripper line change

DeviceMitraClip NTR/XTR Delivery System
Generic NameMitral Valve Repair Devices
ApplicantABBOTT VASCULAR INC.
Date Received2021-03-31
Decision Date2021-06-03
PMAP100009
SupplementS042
Product CodeNKM 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P100009Original Filing
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.