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

FDA Premarket Approval P100009 S049

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

DeviceMitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System
Generic NameMitral Valve Repair Devices
ApplicantAbbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS049 Date Received11/09/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-11-09
Decision Date2022-11-20
PMAP100009
SupplementS049
Product CodeNKM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Medical
177 Country Road B East
st. Paul, MN 55117 PMA NumberP100009 Supplement NumberS049 Date Received11/09/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Modify The Flexural Rigidity Acceptance Criteria For The MitraClip Delivery Catheter Shaft Component

Supplemental Filings

Supplement NumberDateSupplement Type
P100009Original Filing
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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