GELFOAM

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval N18286 S004

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

• Device: GELFOAM
• Classification Name: Agent, Absorbable Hemostatic, Collagen Based
• Generic Name: Agent, Absorbable Hemostatic, Collagen Based
• Applicant: PFIZER, INC.
• Date Received: 1989-11-27
• Decision Date: 1990-05-23
• PMA: N18286
• Supplement: S004
• Product Code: LMF
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: PFIZER, INC. 235 East 42nd St. new York, NY 10017

Supplemental Filings

Supplement Number	Date	Supplement Type
N18286		Original Filing
S040	2022-05-27	Special (immediate Track)
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 ID	PMA	Supp
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