Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form

FDA Premarket Approval P810006 S100

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

DeviceCollastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantINTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-06
Decision Date2022-07-06
PMAP810006
SupplementS100
Product CodeLMF 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressINTEGRA LIFESCIENCES CORPORATION
311 Enterprise Dr.
plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF  Advisory Committee General & Plastic Surgery 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
P810006Original Filing
S100 2022-06-06 30-day Notice
S099 2022-04-20 30-day Notice
S098 2022-04-04 30-day Notice
S097 2021-07-16 30-day Notice
S096
S095
S094 2021-01-27 30-day Notice
S093 2021-01-07 30-day Notice
S092 2020-12-23 30-day Notice
S091 2020-10-19 30-day Notice
S090 2020-08-05 30-day Notice
S089 2019-05-28 30-day Notice
S088 2019-04-08 30-day Notice
S087 2019-04-08 30-day Notice
S086 2019-03-27 30-day Notice
S085 2019-03-21 30-day Notice
S084 2019-02-13 30-day Notice
S083
S082 2018-04-20 30-day Notice
S081 2018-03-26 30-day Notice
S080 2018-01-11 30-day Notice
S079 2017-12-22 135 Review Track For 30-day Notice
S078 2017-09-29 30-day Notice
S077 2017-08-02 30-day Notice
S076 2017-03-31 30-day Notice
S075 2017-01-30 30-day Notice
S074 2016-11-07 30-day Notice
S073 2016-08-19 30-day Notice
S072 2016-05-25 30-day Notice
S071 2016-02-26 135 Review Track For 30-day Notice
S070 2016-02-19 30-day Notice
S069
S068 2015-08-24 135 Review Track For 30-day Notice
S067
S066
S065 2015-03-30 30-day Notice
S064 2015-03-23 30-day Notice
S063 2015-03-20 30-day Notice
S062 2015-03-18 30-day Notice
S061 2015-03-02 30-day Notice
S060 2015-02-24 30-day Notice
S059 2015-02-18 30-day Notice
S058 2014-11-20 30-day Notice
S057 2014-10-21 30-day Notice
S056 2014-09-22 30-day Notice
S055 2014-09-15 30-day Notice
S054
S053 2014-04-11 135 Review Track For 30-day Notice
S052 2014-04-10 30-day Notice
S051 2014-04-10 30-day Notice
S050 2013-12-20 30-day Notice
S049 2013-11-06 135 Review Track For 30-day Notice
S048 2013-11-01 135 Review Track For 30-day Notice
S047 2013-08-14 135 Review Track For 30-day Notice
S046 2013-08-14 135 Review Track For 30-day Notice
S045 2013-08-01 30-day Notice
S044 2013-07-31 30-day Notice
S043 2013-05-28 30-day Notice
S042 2013-05-23 30-day Notice
S041 2013-05-22 30-day Notice
S040 2013-05-21 30-day Notice
S039 2013-05-16 30-day Notice
S038 2013-05-15 30-day Notice
S037 2013-05-14 30-day Notice
S036 2013-05-01 135 Review Track For 30-day Notice
S035 2012-08-31 30-day Notice
S034 2012-08-23 30-day Notice
S033 2010-05-24 30-day Notice
S032 2009-02-02 Normal 180 Day Track No User Fee
S031 2008-03-17 30-day Notice
S030 2007-10-01 30-day Notice
S029 2007-09-05 30-day Notice
S028 2007-06-22 30-day Notice
S027 2007-01-12 30-day Notice
S026 2006-12-12 30-day Notice
S025 2006-11-28 30-day Notice
S024 2006-10-11 30-day Notice
S023 2005-12-06 30-day Notice
S022 2005-09-30 Normal 180 Day Track No User Fee
S021 2003-04-11 30-day Notice
S020 2001-06-08 Real-time Process
S019 1995-07-26 Normal 180 Day Track
S018 1993-06-18 Normal 180 Day Track
S017 1993-03-11 Normal 180 Day Track
S016 1992-06-24 Normal 180 Day Track
S015
S014
S013 1991-05-20 Normal 180 Day Track
S012 1989-04-24 Normal 180 Day Track
S011 1988-12-29 Normal 180 Day Track
S010
S009 1988-10-17 Normal 180 Day Track
S008 1985-09-06
S007 1985-03-05
S006 1984-05-22
S005 1983-08-19
S004
S003 1983-05-09
S002 1982-02-11
S001 1982-01-27

NIH GUDID Devices

Device IDPMASupp
30705031003211 P810006 013
30705031003198 P810006 013

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