Coseal Surgical Sealant; Coseal Spray Set

FDA Premarket Approval P030039 S027

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

Several manufacturing changes to the syringe clip component of the coseal surgical sealant product

DeviceCoseal Surgical Sealant; Coseal Spray Set
Generic NameSealant, Polymerizing
ApplicantBAXTER BIO SCIENCE
Date Received2021-09-28
Decision Date2021-10-27
PMAP030039
SupplementS027
Product CodeNBE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
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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