DURASEAL EXACT SPINE SEALANT SYSTEM

Sealant, Dural

FDA Premarket Approval P080013

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 xact sealant system. The device is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

• Device: DURASEAL EXACT SPINE SEALANT SYSTEM
• Classification Name: Sealant, Dural
• Generic Name: Sealant, Dural
• Applicant: INTEGRA LIFESCIENCES CORPORATION
• Date Received: 2008-04-25
• Decision Date: 2009-09-04
• Notice Date: 2009-10-06
• PMA: P080013
• Supplement: S
• Product Code: NQR
• Docket Number: 09M-0485
• 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
P080013		Original Filing
S024	2022-09-07	30-day Notice
S023	2021-10-18	30-day Notice
S022
S021	2020-08-17	30-day Notice
S020	2020-06-23	Special (immediate Track)
S019
S018	2019-12-30	Normal 180 Day Track No User Fee
S017	2019-06-11	30-day Notice
S016	2018-10-29	30-day Notice
S015	2017-11-30	Normal 180 Day Track No User Fee
S014	2017-07-28	Normal 180 Day Track No User Fee
S013	2016-04-18	Real-time Process
S012
S011	2015-02-02	Normal 180 Day Track No User Fee
S010
S009	2013-06-04	135 Review Track For 30-day Notice
S008	2013-03-25	Normal 180 Day Track No User Fee
S007	2011-07-20	Special (immediate Track)
S006	2011-03-21	Normal 180 Day Track No User Fee
S005
S004	2011-03-02	Normal 180 Day Track No User Fee
S003	2010-01-20	Normal 180 Day Track
S002	2009-10-14	Real-time Process
S001	2009-10-06	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
30381780000048	P080013	009
30381780000031	P080013	009