INTEGRA DERMAL REGENERATION TEMPLATE

Device, Dermal Replacement

FDA Premarket Approval P900033 S008

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 the integra dermal regeneration template. This device is indicated for "the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra dermal regeneration template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient. "

DeviceINTEGRA DERMAL REGENERATION TEMPLATE
Classification NameDevice, Dermal Replacement
Generic NameDevice, Dermal Replacement
ApplicantIntegra LifeSciences Corp.
Date Received2001-10-26
Decision Date2002-04-19
Notice Date2002-05-13
PMAP900033
SupplementS008
Product CodeMDD
Docket Number02M-0216
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Integra LifeSciences Corp. 105 Morgan Ln. plainsboro, NJ 08536
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P900033Original Filing
S103 2022-11-14 30-day Notice
S102 2022-06-07 30-day Notice
S101
S100 2022-04-20 30-day Notice
S099 2022-04-04 30-day Notice
S098
S097 2021-07-16 30-day Notice
S096 2021-06-09 30-day Notice
S095
S094
S093 2021-01-27 30-day Notice
S092 2020-12-23 30-day Notice
S091 2020-10-19 30-day Notice
S090 2020-09-17 30-day Notice
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
M269320211 P900033 011
M269381051 P900033 011
M269341051 P900033 011
M269381011 P900033 011
M269341011 P900033 011
M269340551 P900033 011
M269340511 P900033 011
M269320251 P900033 011
M269MDRT81011 P900033 033
M269MDRT40511 P900033 033
M269MDRT20211 P900033 033
M269MDRT41011 P900033 033
10381780125747 P900033 042
10381780125785 P900033 042
10381780125754 P900033 053
10381780125792 P900033 053
10381780258872 P900033 058
10381780258889 P900033 058

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