VASCULAR CLOSURE SYSTEMS

Device, Hemostasis, Vascular

FDA Premarket Approval P050007 S014

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 manufacturing site located at sterigenics us, inc. , santa teresa, new mexico for ethylene oxide sterilization.

DeviceVASCULAR CLOSURE SYSTEMS
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantABBOTT VASCULAR DEVICES
Date Received2009-05-28
Decision Date2009-07-09
PMAP050007
SupplementS014
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 ABBOTT VASCULAR DEVICES 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P050007Original Filing
S043 2022-11-21 135 Review Track For 30-day Notice
S042 2022-11-16 30-day Notice
S041 2021-05-18 30-day Notice
S040 2020-11-05 30-day Notice
S039 2020-03-06 30-day Notice
S038 2019-04-24 30-day Notice
S037 2018-11-13 Normal 180 Day Track No User Fee
S036 2018-04-02 30-day Notice
S035 2018-03-23 30-day Notice
S034 2016-11-21 30-day Notice
S033 2015-02-25 Normal 180 Day Track No User Fee
S032 2014-09-12 30-day Notice
S031 2013-07-18 135 Review Track For 30-day Notice
S030 2012-06-12 30-day Notice
S029 2011-07-18 30-day Notice
S028 2011-02-22 Special (immediate Track)
S027 2010-10-05 Real-time Process
S026 2010-05-06 30-day Notice
S025 2010-04-23 30-day Notice
S024 2010-02-23 Real-time Process
S023 2009-11-02 Real-time Process
S022 2009-09-11 30-day Notice
S021 2009-09-10 30-day Notice
S020 2009-08-20 30-day Notice
S019 2009-08-04 30-day Notice
S018 2009-08-04 30-day Notice
S017 2009-07-22 30-day Notice
S016 2009-07-06 30-day Notice
S015 2009-06-30 135 Review Track For 30-day Notice
S014 2009-05-28 Normal 180 Day Track No User Fee
S013 2009-03-02 Real-time Process
S012 2008-08-22 30-day Notice
S011 2008-08-15 30-day Notice
S010 2008-07-02 Special (immediate Track)
S009 2008-03-31 Normal 180 Day Track
S008 2007-12-20 30-day Notice
S007 2007-12-12 30-day Notice
S006 2007-05-07 Real-time Process
S005 2007-02-21 30-day Notice
S004 2006-10-24 Real-time Process
S003 2006-07-05 Real-time Process
S002 2006-02-09 Special (immediate Track)
S001 2005-12-27 Panel Track

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