HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P850010 S061

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

Qualification of two new spectrophotometers.

DeviceHELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Classification NameAgent, Absorbable Hemostatic, Collagen Based
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantINTEGRA LIFESCIENCES CORPORATION
Date Received2015-03-18
Decision Date2015-04-14
PMAP850010
SupplementS061
Product CodeLMF
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Dr. plainsboro, NJ 08540

Supplemental Filings

Supplement NumberDateSupplement Type
P850010Original Filing
S104 2022-11-21 30-day Notice
S103 2022-06-06 30-day Notice
S102 2022-04-20 30-day Notice
S101 2022-04-04 30-day Notice
S100 2022-03-21 30-day Notice
S099 2021-07-16 30-day Notice
S098
S097
S096 2021-03-31 30-day Notice
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 2018-09-14 Normal 180 Day Track No User Fee
S081 2018-04-20 30-day Notice
S080 2018-03-26 30-day Notice
S079 2018-01-11 30-day Notice
S078 2017-12-22 135 Review Track For 30-day Notice
S077 2017-09-29 30-day Notice
S076 2017-08-02 30-day Notice
S075 2017-03-31 30-day Notice
S074 2017-01-30 30-day Notice
S073 2016-11-07 30-day Notice
S072 2016-08-19 30-day Notice
S071 2016-05-25 30-day Notice
S070 2016-02-26 135 Review Track For 30-day Notice
S069 2016-02-19 30-day Notice
S068
S067 2015-08-24 135 Review Track For 30-day Notice
S066
S065
S064 2015-03-30 30-day Notice
S063 2015-03-23 30-day Notice
S062 2015-03-20 30-day Notice
S061 2015-03-18 30-day Notice
S060 2015-03-02 30-day Notice
S059 2015-02-24 30-day Notice
S058 2015-02-18 30-day Notice
S057 2014-11-20 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 2014-03-26 30-day Notice
S049 2013-12-20 30-day Notice
S048 2013-11-21 30-day Notice
S047 2013-11-06 135 Review Track For 30-day Notice
S046 2013-11-01 135 Review Track For 30-day Notice
S045 2013-08-14 135 Review Track For 30-day Notice
S044 2013-08-14 135 Review Track For 30-day Notice
S043 2013-08-01 30-day Notice
S042 2013-07-31 30-day Notice
S041 2013-05-28 30-day Notice
S040 2013-05-22 30-day Notice
S039 2013-05-21 30-day Notice
S038 2013-05-20 30-day Notice
S037 2013-05-20 30-day Notice
S036 2013-05-16 30-day Notice
S035 2013-05-15 30-day Notice
S034 2013-05-14 30-day Notice
S033 2013-05-01 135 Review Track For 30-day Notice
S032 2012-08-31 30-day Notice
S031 2012-08-23 30-day Notice
S030 2010-05-24 30-day Notice
S029 2009-02-02 Normal 180 Day Track No User Fee
S028 2008-03-17 30-day Notice
S027 2007-10-01 30-day Notice
S026 2007-09-05 30-day Notice
S025 2007-06-22 30-day Notice
S024 2007-01-12 30-day Notice
S023 2006-12-12 30-day Notice
S022 2006-11-28 30-day Notice
S021 2006-10-11 30-day Notice
S020 2005-12-06 30-day Notice
S019 2005-09-30 Normal 180 Day Track No User Fee
S018 2003-04-15 30-day Notice
S017 2002-03-15 Real-time Process
S016 2001-06-08 Real-time Process
S015 1995-07-26 Normal 180 Day Track
S014 1992-07-06 Normal 180 Day Track
S013 1991-10-18 Normal 180 Day Track
S012 1990-02-23 Normal 180 Day Track
S011 1990-01-22 Normal 180 Day Track
S010 1988-12-23 Normal 180 Day Track
S009
S008
S007 1987-01-02 Normal 180 Day Track
S006 1987-01-27 Normal 180 Day Track
S005 1987-01-12 Normal 180 Day Track
S004 1986-08-20 Normal 180 Day Track
S003 1986-08-20 Normal 180 Day Track
S002 1986-06-19 30-Day Supplement
S001 1985-12-13

NIH GUDID Devices

Device IDPMASupp
10381780000204 P850010 000
10381780000228 P850010 005
10381780000211 P850010 005
10381780000198 P850010 007
10381780508656 P850010 007
10381780000228 P850010 011
10381780000211 P850010 011

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