DUETT SEALING DEVICE

Device, Hemostasis, Vascular

FDA Premarket Approval P990037 S013

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 in the manufacturing procedures to propose reduction in pouch and seal strength tolerance, tolerance change to the knob base and hub base, changes to the sealing achange in the manufacturing procedures to propose reduction in pouch and seal strength tolerance, tolerance change to the knob base and hub base, changes to the sealing and pilot balloons, sleeve marking changes and reduction in the bioburden monitoring limits for the duett family of sealing devices. Nd pilot balloons, sleeve marking changes and reduction in the bioburden monitoring limits for the duett family of sealing devices.

DeviceDUETT SEALING DEVICE
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantVascular Solutions, Inc.
Date Received2003-01-23
Decision Date2003-02-21
PMAP990037
SupplementS013
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
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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