DURASEAL DURAL SEALANT SYSTEM

Sealant, Dural

FDA Premarket Approval P040034 S025

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 changes to three of the polymer resins used to make the biodome bio-set needless access system that is a component of the peg (polyethylene glycol) vial.

DeviceDURASEAL DURAL SEALANT SYSTEM
Classification NameSealant, Dural
Generic NameSealant, Dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
Date Received2016-04-18
Decision Date2016-07-15
PMAP040034
SupplementS025
Product CodeNQR
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08536

Supplemental Filings

Supplement NumberDateSupplement Type
P040034Original 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 IDPMASupp
10381780000020 P040034 024
10381780000013 P040034 024

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