Helistat Absorbable Collagen Hemostatic Sponge

FDA Premarket Approval P850010 S090

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

A replacement of two yokogawa paperless cycle recorders used in lyophilizer's 1 and 2 in integra's manufacturing facility

DeviceHelistat Absorbable Collagen Hemostatic Sponge
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantINTEGRA LIFESCIENCES CORPORATION
Date Received2020-08-05
Decision Date2020-09-04
PMAP850010
SupplementS090
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
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
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10381780000204 P850010 000
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10381780000198 P850010 007
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10381780508656 P850010 007
10381780000198 P850010 007

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