DuraSeal Dural Sealant System.

FDA Premarket Approval P040034 S034

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

Approval for an additional cleaning step to the existing duraseal dural sealant system and duraseal exact spine sealant system manufacturing processes prior to solution filtering

DeviceDuraSeal Dural Sealant System.
Generic NameSealant, Dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
Date Received2021-10-18
Decision Date2021-11-17
PMAP040034
SupplementS034
Product CodeNQR 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536

Supplemental Filings

Supplement NumberDateSupplement Type
P040034Original Filing
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 IDPMASupp
10381780000020 P040034 024
10381780000013 P040034 024

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