DURASEAL DURAL SEALANT SYSTEM

Sealant, Dural

FDA Premarket Approval P040034

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 duraseal dural sealant system. The device is indicated for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. Duraseal should only be used with autologous duraplasty material.

• Device: DURASEAL DURAL SEALANT SYSTEM
• Classification Name: Sealant, Dural
• Generic Name: Sealant, Dural
• Applicant: INTEGRA LIFESCIENCES CORPORATION
• Date Received: 2004-07-20
• Decision Date: 2005-04-07
• Notice Date: 2005-05-18
• PMA: P040034
• Supplement: S
• Product Code: NQR
• Docket Number: 05M-0191
• Advisory Committee: Neurology
• Expedited Review: No
• Combination Product: No
• Applicant Address: INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P040034		Original Filing
S035	2022-09-07	30-day Notice
S034	2021-10-18	30-day Notice
S033
S032	2020-08-17	30-day Notice
S031	2020-05-15	Real-time Process
S030	2019-12-30	Normal 180 Day Track No User Fee
S029	2019-06-11	30-day Notice
S028	2018-10-29	30-day Notice
S027	2017-11-30	Normal 180 Day Track No User Fee
S026	2017-07-21	30-day Notice
S025	2016-04-18	Real-time Process
S024	2014-07-08	Normal 180 Day Track
S023	2014-02-11	30-day Notice
S022
S021	2013-06-04	135 Review Track For 30-day Notice
S020	2011-08-25	135 Review Track For 30-day Notice
S019	2010-12-23	Special (immediate Track)
S018
S017	2010-08-20	30-day Notice
S016	2010-01-08	Normal 180 Day Track No User Fee
S015	2009-10-26	30-day Notice
S014	2009-10-13	Real-time Process
S013	2009-08-11	Real-time Process
S012	2009-07-29	30-day Notice
S011	2009-06-23	Normal 180 Day Track No User Fee
S010
S009	2007-05-15	Real-time Process
S008	2007-03-01	30-day Notice
S007	2006-08-24	Real-time Process
S006	2006-07-28	Normal 180 Day Track
S005	2006-06-13	Normal 180 Day Track No User Fee
S004	2006-06-08	Normal 180 Day Track
S003	2006-05-24	Normal 180 Day Track No User Fee
S002	2005-11-17	Real-time Process
S001	2005-09-01	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
10381780000020	P040034	024
10381780000013	P040034	024