TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Premarket Approval P990040

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 trufill(r) n-butyl cyanoacrylate (n-bca) liquid embolic system. The device is indicated for the embolization of cerebral arteriovenous malformations (avms) when presurgical devascularization is desired.

• Device: TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
• Classification Name: Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
• Generic Name: Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
• Applicant: CODMAN & SHURTLEFF, INC.
• Date Received: 1999-07-16
• Decision Date: 2000-09-25
• Notice Date: 2000-10-20
• PMA: P990040
• Supplement: S
• Product Code: KGG
• Docket Number: 00M-1569
• Advisory Committee: Neurology
• Expedited Review: No
• Combination Product: No
• Applicant Address: CODMAN & SHURTLEFF, INC. 325 Paramount Drive raynham, MA 02767-0350
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P990040		Original Filing
S029	2019-02-19	Normal 180 Day Track
S028	2018-11-15	30-day Notice
S027	2018-11-02	Normal 180 Day Track No User Fee
S026	2018-05-29	30-day Notice
S025	2017-06-08	30-day Notice
S024	2017-01-31	Normal 180 Day Track
S023	2016-11-14	30-day Notice
S022	2016-04-18	Normal 180 Day Track
S021	2015-08-28	30-day Notice
S020	2015-02-18	Real-time Process
S019	2014-09-17	Real-time Process
S018
S017	2013-09-16	135 Review Track For 30-day Notice
S016	2010-11-24	30-day Notice
S015	2010-11-08	Real-time Process
S014	2010-10-12	30-day Notice
S013	2010-08-18	135 Review Track For 30-day Notice
S012	2010-07-28	Real-time Process
S011	2010-05-10	30-day Notice
S010	2009-11-13	30-day Notice
S009	2009-08-31	Normal 180 Day Track No User Fee
S008	2009-03-13	30-day Notice
S007	2008-12-19	30-day Notice
S006	2007-11-01	30-day Notice
S005	2007-07-20	135 Review Track For 30-day Notice
S004	2006-04-28	Special (immediate Track)
S003	2006-02-09	30-day Notice
S002	2006-02-09	30-day Notice
S001	2001-03-01	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
10886704029151	P990040	001
10886704029144	P990040	001
10886704085324	P990040	031
10886704085317	P990040	031