FDA Premarket Approval P950034 S052

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 to the clean hold time of a vessel used in the manufacturing process of seprafilm adhesion barrier

Generic NameBarrier, Absorbable, Adhesion
ApplicantBaxter Healthcare Corporation
Date Received2021-03-05
Decision Date2021-04-01
Product CodeMCN 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Baxter Healthcare Corporation one Baxter Parkway deerfield, IL 60015

Supplemental Filings

Supplement NumberDateSupplement Type
P950034Original Filing
S052 2021-03-05 30-day Notice
S050 2018-02-08 30-day Notice
S049 2017-09-27 30-day Notice
S048 2017-08-04 30-day Notice
S047 2016-12-23 Special (immediate Track)
S046 2016-10-18 30-day Notice
S045 2015-12-15 30-day Notice
S044 2015-12-10 30-day Notice
S043 2015-10-29 30-day Notice
S042 2014-07-14 30-day Notice
S041 2012-02-16 Normal 180 Day Track No User Fee
S040 2011-06-13 135 Review Track For 30-day Notice
S039 2010-12-10 30-day Notice
S038 2010-11-22 30-day Notice
S037 2010-10-29 Real-time Process
S036 2010-10-08 30-day Notice
S035 2010-09-27 30-day Notice
S034 2010-09-07 30-day Notice
S033 2010-08-16 30-day Notice
S032 2009-11-02 30-day Notice
S031 2008-06-09 Special (immediate Track)
S028 2005-11-18 30-day Notice
S027 2005-01-06 Normal 180 Day Track No User Fee
S026 2003-08-05 Real-time Process
S025 2003-04-30 30-day Notice
S024 2003-03-27 30-day Notice
S023 2003-02-25 30-day Notice
S022 2002-09-24 Real-time Process
S021 2002-03-01 30-day Notice
S020 2001-08-29 30-day Notice
S018 2001-08-20 Real-time Process
S017 2000-11-28 Real-time Process
S016 2000-05-30 Real-time Process
S015 2000-05-24 30-day Notice
S014 2000-02-18 Real-time Process
S013 1999-08-09 30-day Notice
S012 1999-08-03 30-day Notice
S011 1999-02-11 Real-time Process
S010 1998-12-22 30-day Notice
S008 1998-01-28 Real-time Process
S007 1997-08-19 Normal 180 Day Track
S006 1997-06-02 Real-time Process
S005 1997-04-16 Real-time Process
S003 1996-11-22 Real-time Process
S002 1996-11-18 Normal 180 Day Track
S001 1996-10-22 Real-time Process


Device IDPMASupp
00358468664211 P950034 000
00358468664112 P950034 000
00358468430120 P950034 000
00358468508621 P950034 017
00358468638014 P950034 037

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