COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Material, Dressing, Surgical, Polylactic Acid

FDA Premarket Approval P840062 S015

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

Upgrade of production processing equipment and changing a manual process to an automated process.

DeviceCOLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Classification NameMaterial, Dressing, Surgical, Polylactic Acid
Generic NameMaterial, Dressing, Surgical, Polylactic Acid
ApplicantINTEGRA LIFESCIENCES CORP.
Date Received2007-09-05
Decision Date2007-10-03
PMAP840062
SupplementS015
Product CodeLPG
Advisory CommitteeDental
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address INTEGRA LIFESCIENCES CORP. 311 Enterprise Dr. plainsboro, NJ 08536

Supplemental Filings

Supplement NumberDateSupplement Type
P840062Original Filing
S086 2022-06-06 30-day Notice
S085 2022-04-20 30-day Notice
S084 2022-04-04 30-day Notice
S083 2021-07-16 30-day Notice
S082
S081
S080
S079 2021-01-27 30-day Notice
S078 2020-12-23 30-day Notice
S077 2020-10-19 30-day Notice
S076 2019-05-28 30-day Notice
S075 2019-04-08 30-day Notice
S074 2019-04-08 30-day Notice
S073 2019-03-27 30-day Notice
S072 2019-03-21 30-day Notice
S071 2019-02-13 30-day Notice
S070 2018-10-31 30-day Notice
S069
S068 2018-08-27 Normal 180 Day Track No User Fee
S067 2018-05-01 Normal 180 Day Track No User Fee
S066 2018-04-20 30-day Notice
S065 2018-03-26 30-day Notice
S064 2018-01-11 30-day Notice
S063 2017-12-22 135 Review Track For 30-day Notice
S062 2017-03-31 30-day Notice
S061 2017-01-30 30-day Notice
S060 2017-01-17 30-day Notice
S059 2016-12-21 30-day Notice
S058 2016-11-07 30-day Notice
S057 2016-08-19 30-day Notice
S056 2016-02-26 135 Review Track For 30-day Notice
S055 2016-02-19 30-day Notice
S054 2015-12-28 30-day Notice
S053
S052 2015-08-24 135 Review Track For 30-day Notice
S051
S050
S049 2015-03-30 30-day Notice
S048 2015-03-23 30-day Notice
S047 2015-03-20 30-day Notice
S046 2015-03-18 30-day Notice
S045 2015-03-02 30-day Notice
S044 2015-02-24 30-day Notice
S043 2014-09-22 30-day Notice
S042 2014-09-15 30-day Notice
S041
S040 2014-04-11 135 Review Track For 30-day Notice
S039 2014-04-10 30-day Notice
S038 2014-04-10 30-day Notice
S037 2013-12-20 30-day Notice
S036 2013-11-06 135 Review Track For 30-day Notice
S035 2013-11-01 135 Review Track For 30-day Notice
S034 2013-08-14 135 Review Track For 30-day Notice
S033 2013-08-05 135 Review Track For 30-day Notice
S032 2013-08-01 30-day Notice
S031 2013-07-31 30-day Notice
S030 2013-05-28 30-day Notice
S029 2013-05-21 30-day Notice
S028 2013-05-16 30-day Notice
S027 2013-05-15 30-day Notice
S026 2013-05-14 30-day Notice
S025 2013-05-01 135 Review Track For 30-day Notice
S024 2012-08-31 30-day Notice
S023 2012-08-23 30-day Notice
S022 2011-08-18 Normal 180 Day Track No User Fee
S021 2010-08-27 Normal 180 Day Track No User Fee
S020 2010-05-24 30-day Notice
S019 2009-03-09 Normal 180 Day Track No User Fee
S018 2009-02-02 Normal 180 Day Track No User Fee
S017 2008-03-17 30-day Notice
S016 2007-10-01 30-day Notice
S015 2007-09-05 30-day Notice
S014 2007-07-26 Normal 180 Day Track No User Fee
S013 2007-06-22 30-day Notice
S012 2007-01-12 30-day Notice
S011 2006-10-11 30-day Notice
S010 2005-12-06 30-day Notice
S009 2005-09-30 Normal 180 Day Track No User Fee
S008 2003-04-16 30-day Notice
S007 2000-08-18 Normal 180 Day Track
S006 1995-07-25 Normal 180 Day Track
S005
S004 1992-10-26 Normal 180 Day Track
S003 1991-10-17 Normal 180 Day Track
S002 1990-02-23 Normal 180 Day Track
S001 1985-11-27 Normal 180 Day Track

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