CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery

FDA Premarket Approval P840062 S086

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

DeviceCollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery
Generic NameMaterial, Dressing, Surgical, Polylactic Acid
ApplicantINTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS086 Date Received06/06/2022 Decision Date07/06/2022 Product Code LPG  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-06
Decision Date2022-07-06
PMAP840062
SupplementS086
Product CodeLPG 
Advisory CommitteeDental
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressINTEGRA LIFESCIENCES CORP.
311 Enterprise Dr.
plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS086 Date Received06/06/2022 Decision Date07/06/2022 Product Code LPG  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Replacement Of The Honeywell Temperature Recorders With The Viewpoint Temperature Monitoring System At The Collagen Manufacturing Center (CMC) Located At 105 Morgan Lane, 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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