Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator

Sealant, Polymerizing

FDA Premarket Approval P030039 S023

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 implementing a new sterilization chamber and cycle for the coseal spray set.

DeviceCoseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
Classification NameSealant, Polymerizing
Generic NameSealant, Polymerizing
ApplicantBAXTER BIO SCIENCE
Date Received2018-05-03
Decision Date2018-07-26
PMAP030039
SupplementS023
Product CodeNBE
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S027 2021-09-28 30-day Notice
S026 2021-04-21 Normal 180 Day Track
S025 2020-04-17 Real-time Process
S024
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
S018
S017
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
S006
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

NIH GUDID Devices

Device IDPMASupp
35413765583415 P030039 024

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