AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval N17600 S015

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 the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of avitene mch flur, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized.

• Device: AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
• Classification Name: Agent, Absorbable Hemostatic, Collagen Based
• Generic Name: Agent, Absorbable Hemostatic, Collagen Based
• Applicant: DAVOL, INC., SUB. C.R. BARD, INC.
• Date Received: 1998-07-21
• Decision Date: 1998-08-10
• PMA: N17600
• Supplement: S015
• Product Code: LMF
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: DAVOL, INC., SUB. C.R. BARD, INC. 100 Crossings Boulevard warwick, RI 02886

Supplemental Filings

Supplement Number	Date	Supplement Type
N17600		Original Filing
S035	2021-01-19	30-day Notice
S034
S033	2020-02-28	30-day Notice
S032	2019-05-20	30-day Notice
S031	2018-12-03	30-day Notice
S030	2018-06-28	30-day Notice
S029	2014-05-30	30-day Notice
S028	2013-06-24	30-day Notice
S027	2013-05-28	30-day Notice
S026	2011-12-22	Special (immediate Track)
S025	2011-09-02	30-day Notice
S024	2009-03-20	30-day Notice
S023	2005-09-08	30-day Notice
S022
S021	2004-10-04	30-day Notice
S020	2003-06-11	30-day Notice
S019	2001-10-18	Real-time Process
S018	2001-05-23	30-day Notice
S017	2000-12-14	Normal 180 Day Track
S016	1998-12-21	Real-time Process
S015	1998-07-21	30-day Notice
S014	1995-03-16	Normal 180 Day Track
S013	1995-01-23	Normal 180 Day Track
S012	1994-06-07	Normal 180 Day Track
S011	1993-08-23	Normal 180 Day Track
S010	1991-10-07	Normal 180 Day Track
S009	1986-09-16	Special (immediate Track)
S008	1983-08-26
S007	1982-02-02
S006
S005	1981-08-20
S004	1980-07-21
S003	1980-07-08
S002	1980-06-16
S001	1980-01-28

NIH GUDID Devices

Device ID	PMA	Supp
10801741000383	N17600	000
10801741010436	N17600	000
10801741010511	N17600	000
10801741000383	N17600	001
10801741010436	N17600	001
10801741010511	N17600	001
10801741010504	N17600	011
10801741010528	N17600	016
10801741010535	N17600	016
10801741010542	N17600	016
10801741010559	N17600	016
10801741223102	N17600	038