Duett Sealing

FDA Premarket Approval P990037 S035

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

An alternate sealer for the sterile barrier of the d-stat flowable hemostat of the duett sealing device

DeviceDuett Sealing
Generic NameDevice, Hemostasis, Vascular
ApplicantVascular Solutions, Inc.
Date Received2021-06-14
Decision Date2021-07-13
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Vascular Solutions, Inc. 6464 Sycamore Court North minneapolis, MN 55369

Supplemental Filings

Supplement NumberDateSupplement Type
P990037Original Filing
S035 2021-06-14 30-day Notice
S034 2016-09-09 30-day Notice
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
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
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
S003 2001-02-07 Real-time Process
S002 2001-01-22 Real-time Process
S001 2000-10-04 Normal 180 Day Track

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.