VASCULAR SOLUTION DUETT SEALING DEVICE

Device, Hemostasis, Vascular

FDA Premarket Approval P990037 S008

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 delivery cannulae and the procoagulant and changing the buffering agent in the dilutent to tromethamine usp (tris). The device, as modified, will be marketed under the trade name duett flowable hemostat device and is indicated for use as adjunct treatment in obtaining hemostasis in sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture mediated/collagen-based hemostatic devices.

DeviceVASCULAR SOLUTION DUETT SEALING DEVICE
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantVascular Solutions, Inc.
Date Received2001-12-11
Decision Date2002-05-29
PMAP990037
SupplementS008
Product CodeMGB
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Vascular Solutions, Inc. 6464 Sycamore Court North minneapolis, MN 55369

Supplemental Filings

Supplement NumberDateSupplement Type
P990037Original Filing
S036 2022-08-08 Normal 180 Day Track
S035 2021-06-14 30-day Notice
S034 2016-09-09 30-day Notice
S033
S032 2016-01-29 Special (immediate Track)
S031 2010-07-30 Normal 180 Day Track No User Fee
S030 2010-04-09 30-day Notice
S029 2009-11-04 30-day Notice
S028 2008-10-21 Real-time Process
S027
S026 2008-07-11 30-day Notice
S025 2007-06-14 Special (immediate Track)
S024 2006-06-22 Panel Track
S023 2005-08-05 Special (immediate Track)
S022 2004-06-15 Normal 180 Day Track No User Fee
S021 2004-06-15 Real-time Process
S020 2003-06-18 30-day Notice
S019 2003-05-16 Real-time Process
S018 2003-04-30 Normal 180 Day Track No User Fee
S017
S016
S015 2003-03-11 Real-time Process
S014 2003-02-24 Special (immediate Track)
S013 2003-01-23 30-day Notice
S012 2003-01-17 Real-time Process
S011 2002-08-26 30-day Notice
S010 2002-02-27 Normal 180 Day Track
S009 2002-03-15 Real-time Process
S008 2001-12-11 Normal 180 Day Track
S007 2001-11-28 Special (immediate Track)
S006 2001-05-21 Special (immediate Track)
S005 2001-05-01 Normal 180 Day Track
S004
S003 2001-02-07 Real-time Process
S002 2001-01-22 Real-time Process
S001 2000-10-04 Normal 180 Day Track

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