Coseal Surgical Sealant

FDA Premarket Approval P030039 S025

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

A shelf-life extension from 6 months to 12 months

DeviceCoseal Surgical Sealant
Generic NameSealant, Polymerizing
Date Received2020-04-17
Decision Date2020-07-16
Product CodeNBE 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BAXTER BIO SCIENCE 32650 N Wilson Rd mail Stop Wg2-3s round Lake, IL 60073

Supplemental Filings

Supplement NumberDateSupplement Type
P030039Original Filing
S025 2020-04-17 Real-time Process
S023 2018-05-03 Real-time Process
S022 2018-02-20 30-day Notice
S021 2018-01-25 Special (immediate Track)
S020 2017-12-04 Normal 180 Day Track No User Fee
S019 2015-10-16 30-day Notice
S016 2010-06-01 Special (immediate Track)
S015 2010-03-02 Special (immediate Track)
S014 2009-09-04 Real-time Process
S013 2009-03-17 135 Review Track For 30-day Notice
S012 2008-11-07 30-day Notice
S011 2008-08-29 Special (immediate Track)
S010 2008-07-01 Real-time Process
S009 2008-03-24 30-day Notice
S008 2007-11-15 30-day Notice
S007 2007-10-31 30-day Notice
S005 2007-06-25 30-day Notice
S004 2006-04-05 Normal 180 Day Track
S003 2006-02-02 Special (immediate Track)
S002 2006-01-17 Normal 180 Day Track No User Fee
S001 2003-12-18 Normal 180 Day Track No User Fee

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