Mynx Control and Mynx Grip Vascular Closure

FDA Premarket Approval P040044 S088

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

Use of an additional supplier for the syringe component used in the mynxgrip and mynx control vascular closure devices

DeviceMynx Control and Mynx Grip Vascular Closure
Generic NameDevice, Hemostasis, Vascular
ApplicantCordis US Corporation
Date Received2021-10-08
Decision Date2021-11-05
PMAP040044
SupplementS088
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cordis US Corporation 14201 Nw 60th Avenue miami Lakes, FL 33014

Supplemental Filings

Supplement NumberDateSupplement Type
P040044Original Filing
S088 2021-10-08 30-day Notice
S087 2021-10-07 30-day Notice
S086 2021-09-01 30-day Notice
S085 2019-09-03 30-day Notice
S084 2019-04-24 30-day Notice
S083 2019-02-12 30-day Notice
S082 2018-08-27 30-day Notice
S081 2018-05-16 Normal 180 Day Track No User Fee
S080 2018-04-02 30-day Notice
S079 2018-02-05 Normal 180 Day Track
S078 2017-11-20 Normal 180 Day Track
S077 2017-06-30 Real-time Process
S076 2017-05-01 30-day Notice
S075 2016-11-21 135 Review Track For 30-day Notice
S074 2016-08-29 30-day Notice
S073 2016-06-06 30-day Notice
S072 2016-04-04 30-day Notice
S071
S070 2016-01-07 Real-time Process
S069 2016-01-05 30-day Notice
S068 2015-12-07 Normal 180 Day Track No User Fee
S067
S066 2015-09-09 Real-time Process
S065 2015-07-09 30-day Notice
S064 2015-07-02 30-day Notice
S063 2015-03-25 30-day Notice
S062 2014-12-19 Real-time Process
S061 2014-12-12 30-day Notice
S060 2014-12-12 30-day Notice
S059 2014-11-12 Real-time Process
S058 2014-10-30 30-day Notice
S057 2014-05-23 Real-time Process
S056 2014-05-02 Normal 180 Day Track
S055 2014-04-10 30-day Notice
S054 2014-04-03 Real-time Process
S053 2014-04-01 30-day Notice
S052 2014-03-31 30-day Notice
S051 2014-03-31 30-day Notice
S050 2013-12-26 30-day Notice
S049 2013-08-14 135 Review Track For 30-day Notice
S048 2013-02-22 Real-time Process
S047 2012-12-31 Normal 180 Day Track
S046 2012-12-26 30-day Notice
S045 2012-11-14 Normal 180 Day Track No User Fee
S044 2012-11-06 Real-time Process
S043 2012-02-08 Real-time Process
S042 2011-12-13 30-day Notice
S041 2011-11-21 30-day Notice
S040 2011-11-14 Real-time Process
S039 2011-08-29 135 Review Track For 30-day Notice
S038 2011-05-27 Normal 180 Day Track No User Fee
S037 2011-03-10 Real-time Process
S036 2011-02-10 30-day Notice
S035
S034 2010-09-30 Normal 180 Day Track
S033 2010-08-18 Real-time Process
S032 2010-05-20 Special (immediate Track)
S031 2010-04-02 30-day Notice
S030 2010-04-01 30-day Notice
S029 2010-03-29 30-day Notice
S028 2010-03-04 30-day Notice
S027 2010-02-22 Special (immediate Track)
S026 2010-02-19 30-day Notice
S025 2010-02-12 135 Review Track For 30-day Notice
S024 2009-12-14 30-day Notice
S023 2009-10-29 30-day Notice
S022 2009-10-27 30-day Notice
S021 2009-10-23 Real-time Process
S020 2009-10-22 30-day Notice
S019 2009-09-30 30-day Notice
S018
S017 2009-07-21 30-day Notice
S016 2009-07-15 Real-time Process
S015 2009-06-25 Special (immediate Track)
S014 2009-04-14 Special (immediate Track)
S013 2009-04-13 30-day Notice
S012 2009-03-19 Special (immediate Track)
S011 2009-02-17 Real-time Process
S010 2008-11-13 Real-time Process
S009 2008-06-04 30-day Notice
S008 2008-06-03 Real-time Process
S007 2008-03-31 Normal 180 Day Track No User Fee
S006 2008-03-14 Special (immediate Track)
S005 2008-03-11 135 Review Track For 30-day Notice
S004 2007-11-16 Special (immediate Track)
S003 2007-10-05 30-day Notice
S002 2007-08-24 Special (immediate Track)
S001 2006-04-06 Panel Track

NIH GUDID Devices

Device IDPMASupp
20862028000417 P040044 000
20862028000400 P040044 000
10862028000427 P040044 000

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