Gelfoam (absorbable gelatin) Sterile Sponge

FDA Premarket Approval N18286 S039

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

Requested approval for the addition of text to the gelfoam instructions for use regarding pseudoabscess and pseudoinfection

DeviceGelfoam (absorbable gelatin) Sterile Sponge
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantPFIZER, INC.
Date Received2021-06-10
Decision Date2021-07-08
PMAN18286
SupplementS039
Product CodeLMF 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address PFIZER, INC. 235 East 42nd St. new York, NY 10017

Supplemental Filings

Supplement NumberDateSupplement Type
N18286Original Filing
S039 2021-06-10 Special (immediate Track)
S038 2021-04-09 Special (immediate Track)
S037 2021-01-25 Special (immediate Track)
S036 2020-11-10 Special (immediate Track)
S035 2020-02-18 30-day Notice
S034 2020-01-29 30-day Notice
S033 2019-11-04 30-day Notice
S032 2019-06-06 Special (immediate Track)
S031 2018-03-12 30-day Notice
S030 2018-03-07 Normal 180 Day Track No User Fee
S029 2017-02-23 135 Review Track For 30-day Notice
S028 2016-04-20 Normal 180 Day Track
S027 2014-09-29 30-day Notice
S026 2014-03-12 30-day Notice
S025 2013-04-17 Special (immediate Track)
S024 2012-11-26 Real-time Process
S023 2011-10-13 Special (immediate Track)
S022 2011-09-06 Real-time Process
S021 2011-05-09 Real-time Process
S020 2010-10-12 Special (immediate Track)
S019 2010-03-17 Special (immediate Track)
S018 2009-02-26 Normal 180 Day Track
S017 2007-05-24 Normal 180 Day Track
S016 2007-04-26 30-day Notice
S015
S014 2003-03-05 Special (immediate Track)
S013 2002-02-19 30-day Notice
S012 1999-12-08 Panel Track
S011 1999-04-05 Normal 180 Day Track
S010 1998-09-16 30-day Notice
S009
S008 1995-04-07 Normal 180 Day Track
S007 1992-07-24 Normal 180 Day Track
S006 1991-12-24 Normal 180 Day Track
S005 1991-04-30 Normal 180 Day Track
S004 1989-11-27 Normal 180 Day Track
S003 1989-03-23 Normal 180 Day Track
S002
S001

NIH GUDID Devices

Device IDPMASupp
00360793410104 N18286 017
00300090323011 N18286 017
00300090342012 N18286 017
00300090349035 N18286 017
00300090353018 N18286 017
00300090396053 N18286 017
00300090433048 N18286 017
00300091040061 N18286 017
00360793310107 N18286 017
00300090315085 N18286 017
00300092250018 N18286 028

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