ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE

Device, Hemostasis, Vascular

FDA Premarket Approval P930038 S005

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

Change to the indications for use for the angio-seal(tm) device. The angio-seal(tm) hemostatic puncture closure device is now indicated for use in closing and in reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography or interventional procedures using an retrograde approach and an 8 french or smaller procedural sheath.

DeviceANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantTERUMO MEDICAL CORPORATION
Date Received1997-04-16
Decision Date1997-05-01
PMAP930038
SupplementS005
Product CodeMGB
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address TERUMO MEDICAL CORPORATION 950 Elkton Blvd. elkton, MD 21921

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

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