SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect

FDA Premarket Approval P990004 S051

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

A change to the electron beam (e-beam) equipment located at the current e-beam contract sterilization site for the surgifoam® absorbable gelatin dental sponge, the surgifoam® absorbable gelatin hemorrhoidectomy sponge, and the surgifoam® absorbable gelatin powder

DeviceSURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantFerrosan Meidcal Devices A/S
Date Received2021-11-22
Decision Date2021-12-21
Product CodeLMF 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Ferrosan Meidcal Devices A/S sydmarken 5 soeborg 08876

Supplemental Filings

Supplement NumberDateSupplement Type
P990004Original Filing
S051 2021-11-22 30-day Notice
S050 2021-09-28 30-day Notice
S049 2021-07-26 Special (immediate Track)
S048 2021-05-03 30-day Notice
S047 2021-04-02 30-day Notice
S043 2020-08-26 30-day Notice
S042 2020-07-30 Special (immediate Track)
S041 2020-06-24 30-day Notice
S040 2020-06-08 30-day Notice
S038 2020-03-19 30-day Notice
S037 2020-02-18 30-day Notice
S036 2019-10-01 Special (immediate Track)
S035 2019-02-04 135 Review Track For 30-day Notice
S033 2018-09-05 135 Review Track For 30-day Notice
S032 2017-08-25 30-day Notice
S031 2017-05-04 30-day Notice
S030 2017-02-09 30-day Notice
S029 2016-01-27 30-day Notice
S028 2015-03-06 Normal 180 Day Track No User Fee
S027 2015-02-18 30-day Notice
S026 2015-02-18 30-day Notice
S025 2014-10-24 Normal 180 Day Track
S024 2014-04-22 Normal 180 Day Track No User Fee
S023 2012-10-22 135 Review Track For 30-day Notice
S022 2012-06-18 Special (immediate Track)
S021 2011-02-04 30-day Notice
S019 2010-10-18 Normal 180 Day Track
S018 2010-06-23 Real-time Process
S017 2010-03-02 Real-time Process
S016 2009-07-06 Real-time Process
S015 2008-09-03 30-day Notice
S014 2008-06-27 30-day Notice
S013 2007-07-05 Normal 180 Day Track
S012 2007-06-20 Normal 180 Day Track
S011 2007-03-19 Real-time Process
S010 2006-08-30 Real-time Process
S009 2005-12-20 Real-time Process
S008 2005-03-10 Real-time Process
S007 2004-11-16 Normal 180 Day Track No User Fee
S006 2004-05-10 Real-time Process
S005 2004-01-26 Normal 180 Day Track No User Fee
S004 2002-08-23 Real-time Process
S003 2000-10-02 Real-time Process
S002 1999-11-16 Real-time Process
S001 1999-11-15 Real-time Process


Device IDPMASupp
15712123000158 P990004 001
15712123000172 P990004 002
15712123000189 P990004 002
15712123000202 P990004 002
15712123000226 P990004 003
15712123000264 P990004 004
15712123000240 P990004 004
15712123000325 P990004 008
15712123000288 P990004 008
15712123000318 P990004 008
15712123000141 P990004 010

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