DuraSeal Exact SPine Sealant System

Sealant, Dural

FDA Premarket Approval P080013 S016

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

Use of an additional freezer for the production of duraseal dural sealant system.

• Device: DuraSeal Exact SPine Sealant System
• Classification Name: Sealant, Dural
• Generic Name: Sealant, Dural
• Applicant: INTEGRA LIFESCIENCES CORPORATION
• Date Received: 2018-10-29
• Decision Date: 2018-11-28
• PMA: P080013
• Supplement: S016
• Product Code: NQR
• Docket Number: Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia
• Advisory Committee: Neurology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536

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