Gelfoam (absorbable gelatin) Sterile Sponge

FDA Premarket Approval N18286 S034

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

Implementation of the alternate bulk sterilization procedure for gel-flow nt that is further processed into gel-flow kits and the addition of the protective laminate coating and update to the ribbon stock for the gel-flow nt outer pouch label

DeviceGelfoam (absorbable gelatin) Sterile Sponge
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantPFIZER, INC.
Date Received2020-01-29
Decision Date2020-02-27
PMAN18286
SupplementS034
Product CodeLMF 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PFIZER, INC. 235 East 42nd St. new York, NY 10017

Supplemental Filings

Supplement NumberDateSupplement Type
N18286Original Filing
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
00360793310107 N18286 017
00300091040061 N18286 017
00300092250018 N18286 028

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