Integra Dermal Regeneration Template

FDA Premarket Approval P900033 S089

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

A replacement of two yokogawa paperless cycle recorders used in lyophilizer's 1 and 2 in integra's manufacturing facility

DeviceIntegra Dermal Regeneration Template
Generic NameDressing, Wound And Burn, Interactive
ApplicantIntegra LifeSciences Corp.
Date Received2020-08-05
Decision Date2020-09-04
PMAP900033
SupplementS089
Product CodeMGR 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Integra LifeSciences Corp. 105 Morgan Ln. plainsboro, NJ 08536

Supplemental Filings

Supplement NumberDateSupplement Type
P900033Original Filing
S089 2020-08-05 30-day Notice
S088
S087
S086 2019-08-07 30-day Notice
S085 2019-07-31 30-day Notice
S084 2019-07-30 30-day Notice
S083 2019-07-29 30-day Notice
S082 2019-07-10 30-day Notice
S081 2019-06-21 30-day Notice
S080 2019-04-08 30-day Notice
S079 2019-04-08 30-day Notice
S078 2019-03-27 30-day Notice
S077 2019-03-21 30-day Notice
S076 2019-02-13 30-day Notice
S075 2019-02-11 30-day Notice
S074 2018-08-31 135 Review Track For 30-day Notice
S073 2018-08-16 30-day Notice
S072 2018-07-12 30-day Notice
S071 2018-06-20 30-day Notice
S070 2018-04-20 30-day Notice
S069 2018-03-26 30-day Notice
S068 2018-03-07 30-day Notice
S067 2017-12-04 30-day Notice
S066 2017-10-30 30-day Notice
S065 2017-10-12 135 Review Track For 30-day Notice
S064
S063 2017-06-29 Normal 180 Day Track No User Fee
S062 2017-06-12 30-day Notice
S061 2017-03-31 30-day Notice
S060 2017-01-30 30-day Notice
S059 2016-12-19 30-day Notice
S058 2016-11-15 Real-time Process
S057 2016-08-24 30-day Notice
S056 2016-08-19 30-day Notice
S055 2016-07-25 30-day Notice
S054 2015-11-24 Normal 180 Day Track No User Fee
S053 2015-11-03 Normal 180 Day Track
S052
S051 2015-08-24 135 Review Track For 30-day Notice
S050
S049
S048 2015-06-03 30-day Notice
S047 2015-05-20 Real-time Process
S046 2015-03-23 30-day Notice
S045 2015-03-18 30-day Notice
S044 2015-03-02 30-day Notice
S043 2015-02-03 30-day Notice
S042 2015-01-29 Panel Track
S041 2014-09-29 135 Review Track For 30-day Notice
S040 2014-09-29 30-day Notice
S039 2014-09-22 30-day Notice
S038 2014-09-15 30-day Notice
S037 2014-06-23 30-day Notice
S036
S035 2014-04-11 135 Review Track For 30-day Notice
S034 2014-04-10 30-day Notice
S033 2014-01-07 Real-time Process
S032 2013-11-01 135 Review Track For 30-day Notice
S031 2013-07-31 30-day Notice
S030 2013-05-28 30-day Notice
S029 2013-05-15 30-day Notice
S028 2013-05-14 30-day Notice
S027 2013-05-01 135 Review Track For 30-day Notice
S026 2013-04-26 135 Review Track For 30-day Notice
S025 2012-07-27 30-day Notice
S024 2012-07-27 30-day Notice
S023 2012-07-25 30-day Notice
S022 2012-07-23 30-day Notice
S021 2011-10-13 Normal 180 Day Track No User Fee
S020 2011-08-01 Normal 180 Day Track No User Fee
S019 2008-03-17 30-day Notice
S018 2007-10-01 30-day Notice
S017 2007-08-24 30-day Notice
S016 2007-05-14 30-day Notice
S015 2007-01-12 30-day Notice
S014 2006-10-11 30-day Notice
S013 2005-12-06 30-day Notice
S012 2004-08-23 30-day Notice
S011 2004-01-02 Real-time Process
S010 2003-11-07 30-day Notice
S009 2003-04-16 30-day Notice
S008 2001-10-26 Panel Track
S007 2001-07-06 Real-time Process
S006 2001-06-19 Real-time Process
S005 2001-04-13 Real-time Process
S004
S003 1999-11-08 30-day Notice
S002 1997-06-30 Real-time Process
S001 1996-08-19 Real-time Process

NIH GUDID Devices

Device IDPMASupp
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