Duett Sealing (D-Stat Flowable)

FDA Premarket Approval P990037 S036

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

DeviceDuett Sealing (D-Stat Flowable)
Generic NameDevice, Hemostasis, Vascular
ApplicantVascular Solutions, Inc.6464 Sycamore Court Northminneapolis, MN 55369 PMA NumberP990037 Supplement NumberS036 Date Received08/08/2022 Decision Date11/04/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-08
Decision Date2022-11-04
PMAP990037
SupplementS036
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVascular Solutions, Inc.
6464 Sycamore Court North
minneapolis, MN 55369 PMA NumberP990037 Supplement NumberS036 Date Received08/08/2022 Decision Date11/04/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Minor Design And Manufacturing Changes To The D-Stat Flowable Device Diluent Vial And Packaging Sealed Tray

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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