STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS

Device, Hemostasis, Vascular

FDA Premarket Approval P050007 S009

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 modifications to the indications for use. The device, as modified, will be indicated for the following: the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5f or 6f procedural sheath. The starclose vascular closure system is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement. The starclose vascular closure system is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone interventional endovascular catheterization procedures utilizing a 5f or 6f procedural sheath.

DeviceSTARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantABBOTT VASCULAR DEVICES
Date Received2008-03-31
Decision Date2008-08-25
PMAP050007
SupplementS009
Product CodeMGB
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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