ANGIO-SEAL VIP Vascular Closure

FDA Premarket Approval P930038 S100

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

DeviceANGIO-SEAL VIP Vascular Closure
Generic NameDevice, Hemostasis, Vascular
ApplicantTERUMO MEDICAL CORPORATION950 Elkton Blvd.elkton, MD 21921 PMA NumberP930038 Supplement NumberS100 Date Received07/28/2022 Decision Date08/26/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-07-28
Decision Date2022-08-26
PMAP930038
SupplementS100
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressTERUMO MEDICAL CORPORATION
950 Elkton Blvd.
elkton, MD 21921 PMA NumberP930038 Supplement NumberS100 Date Received07/28/2022 Decision Date08/26/2022 Product Code MGB  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 Replace A Facility With An Alternative Facility That Will Conduct Bioburden Testing And Sterility Testing Associated With Routine Dose Audits

Supplemental Filings

Supplement NumberDateSupplement Type
P930038Original Filing
S100 2022-07-28 30-day Notice
S099
S098 2020-11-24 30-day Notice
S097 2019-11-18 30-day Notice
S096 2019-05-17 30-day Notice
S095 2019-04-26 30-day Notice
S094 2019-03-21 30-day Notice
S093 2019-02-28 30-day Notice
S092 2019-02-21 30-day Notice
S091 2019-01-22 30-day Notice
S090 2018-12-20 30-day Notice
S089 2018-07-16 30-day Notice
S088 2018-03-28 30-day Notice
S087 2018-03-05 30-day Notice
S086 2017-09-29 30-day Notice
S085 2017-09-25 30-day Notice
S084 2017-02-24 Special (immediate Track)
S083 2016-11-07 135 Review Track For 30-day Notice
S082 2016-04-15 30-day Notice
S081 2016-04-11 30-day Notice
S080 2016-03-28 30-day Notice
S079 2016-02-01 30-day Notice
S078 2015-09-04 Special (immediate Track)
S077 2015-08-21 Normal 180 Day Track No User Fee
S076 2015-05-07 30-day Notice
S075 2015-02-25 30-day Notice
S074 2014-12-01 135 Review Track For 30-day Notice
S073
S072 2014-02-21 30-day Notice
S071 2013-06-03 30-day Notice
S070 2012-01-17 30-day Notice
S069 2011-11-03 30-day Notice
S068 2011-08-09 Real-time Process
S067 2011-07-05 Normal 180 Day Track No User Fee
S066 2011-03-11 30-day Notice
S065 2011-01-27 30-day Notice
S064 2010-11-10 Special (immediate Track)
S063 2010-07-28 30-day Notice
S062 2010-06-11 30-day Notice
S061 2010-01-25 30-day Notice
S060 2009-11-02 30-day Notice
S059
S058 2009-04-15 30-day Notice
S057 2009-03-13 30-day Notice
S056
S055 2008-05-09 30-day Notice
S054 2008-01-22 Real-time Process
S053
S052 2007-12-28 Normal 180 Day Track
S051 2007-10-22 30-day Notice
S050 2007-04-06 30-day Notice
S049 2007-02-28 30-day Notice
S048 2006-10-31 135 Review Track For 30-day Notice
S047 2006-06-02 30-day Notice
S046 2005-10-12 Normal 180 Day Track
S045 2005-08-02 30-day Notice
S044 2005-06-13 Special (immediate Track)
S043 2005-02-08 Real-time Process
S042 2005-01-25 135 Review Track For 30-day Notice
S041 2004-10-21 Real-time Process
S040 2004-08-23 Real-time Process
S039 2004-04-02 Special (immediate Track)
S038 2004-03-10 30-day Notice
S037
S036 2003-03-31 Real-time Process
S035 2002-11-20 Real-time Process
S034 2002-11-05 Real-time Process
S033 2002-02-21 Special (immediate Track)
S032 2001-09-06 30-day Notice
S031 2001-03-20 Normal 180 Day Track
S030 2001-02-13 30-day Notice
S029 2001-01-08 Normal 180 Day Track
S028 2000-12-18 30-day Notice
S027 2000-10-02 Normal 180 Day Track
S026 2000-06-27 Normal 180 Day Track
S025 2000-05-16 Normal 180 Day Track
S024 2000-03-07 Normal 180 Day Track
S023 2000-01-24 Normal 180 Day Track
S022 1999-12-16 Normal 180 Day Track
S021 1999-08-23 30-day Notice
S020 1999-07-19 Normal 180 Day Track
S019 1999-06-28 Normal 180 Day Track
S018 1999-04-05 Normal 180 Day Track
S017 1998-08-07 Real-time Process
S016 1998-06-24 Special (immediate Track)
S015 1998-06-17 Normal 180 Day Track
S014 1998-06-01 Normal 180 Day Track
S013 1998-03-05 Normal 180 Day Track
S012 1997-12-18 Normal 180 Day Track
S011 1997-11-28 Special (immediate Track)
S010 1997-11-25 Normal 180 Day Track
S009 1997-10-24 Special (immediate Track)
S008
S007 1997-08-06 Normal 180 Day Track
S006 1997-06-18 Normal 180 Day Track
S005 1997-04-16 Normal 180 Day Track
S004 1997-03-31 Normal 180 Day Track
S003
S002 1997-03-21
S001 1997-01-28 Normal 180 Day Track

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