SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

Barrier, Absorbable, Adhesion

FDA Premarket Approval P950034

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the seprafilm bioresorbable membrane

• Device: SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
• Classification Name: Barrier, Absorbable, Adhesion
• Generic Name: Barrier, Absorbable, Adhesion
• Applicant: GENZYME CORP.
• Date Received: 1995-10-27
• Decision Date: 1996-08-12
• Notice Date: 1997-04-16
• PMA: P950034
• Supplement: S
• Product Code: MCN
• Docket Number: 97M-0139
• Advisory Committee: General & Plastic Surgery
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: GENZYME CORP. 52 Binney Street cambridge, MA 02142

Supplemental Filings

Supplement Number	Date	Supplement Type
P950034		Original Filing
S055	2022-11-23	30-day Notice
S054
S053	2021-05-11	30-day Notice
S052	2021-03-05	30-day Notice
S051
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)
S030
S029
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
S019
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
S009
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
S004
S003	1996-11-22	Real-time Process
S002	1996-11-18	Normal 180 Day Track
S001	1996-10-22	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00358468664211	P950034	000
35413765589622	P950034	000
35413765589639	P950034	000
35413765589646	P950034	000
35413765589653	P950034	000
00358468430120	P950034	000
00358468664112	P950034	000
35413765589615	P950034	000
00358468508621	P950034	017
00358468638014	P950034	037