DuraSeal Exact Spine Sealant System

FDA Premarket Approval P080013 S020

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

Labeling changes to add additional information on potential risks and adverse events identified in the summary of safety and effectiveness data for the duraseal exact spine sealant system

DeviceDuraSeal Exact Spine Sealant System
Generic NameSealant, Dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
Date Received2020-06-23
Decision Date2020-07-22
PMAP080013
SupplementS020
Product CodeNQR 
Advisory CommitteeNeurology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536

Supplemental Filings

Supplement NumberDateSupplement Type
P080013Original Filing
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 IDPMASupp
30381780000048 P080013 009
30381780000031 P080013 009

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