MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Device, Hemostasis, Vascular

FDA Premarket Approval P040044 S038

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 a contract sterilization site, beamone, llc located in mountain view, california.

DeviceMYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantACCESS CLOSURE, INC.
Date Received2011-05-27
Decision Date2011-07-21
PMAP040044
SupplementS038
Product CodeMGB
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ACCESS CLOSURE, INC. 5452 Betsy Ross Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P040044Original Filing
S093 2022-09-29 30-day Notice
S092 2022-06-02 30-day Notice
S091 2022-03-31 30-day Notice
S090 2021-11-19 30-day Notice
S089
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
10862028000434 P040044 000
M465MX67210 P040044 040
M465MX50210 P040044 043
M465MX67400 P040044 047

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.