Agent, Absorbable Hemostatic, Non-collagen Based

FDA Premarket Approval N12159 S066

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

Add a duplicate analyzer which has the same functionality and will operate within the same specifications as the existing analyzer that is already in use for the manufacture of surgicel powder.

DeviceSURGICEL Powder
Classification NameAgent, Absorbable Hemostatic, Non-collagen Based
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantETHICON, INC.
Date Received2019-10-23
Decision Date2019-11-19
Product CodeLMG
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ETHICON, INC. route 22 West somerville, NJ 08876

Supplemental Filings

Supplement NumberDateSupplement Type
N12159Original Filing
S066 2019-10-23 30-day Notice
S065 2019-09-30 30-day Notice
S064 2019-09-09 30-day Notice
S062 2019-07-15 30-day Notice
S061 2019-07-05 30-day Notice
S060 2019-07-03 30-day Notice
S059 2019-06-24 30-day Notice
S058 2019-06-14 30-day Notice
S056 2019-04-19 30-day Notice
S055 2019-04-17 30-day Notice
S054 2019-03-14 30-day Notice
S053 2019-03-14 Real-time Process
S051 2018-11-08 Special (immediate Track)
S050 2018-10-09 Special (immediate Track)
S049 2018-09-25 Real-time Process
S048 2018-09-20 30-day Notice
S047 2018-05-25 Normal 180 Day Track
S046 2018-01-31 Special (immediate Track)
S044 2017-06-12 30-day Notice
S043 2017-03-03 30-day Notice
S042 2016-09-27 30-day Notice
S041 2016-09-27 30-day Notice
S040 2016-09-02 30-day Notice
S039 2016-08-26 Special (immediate Track)
S038 2016-06-08 30-day Notice
S037 2016-05-20 30-day Notice
S036 2016-02-08 Normal 180 Day Track
S035 2015-10-28 30-day Notice
S034 2015-05-05 30-day Notice
S033 2014-07-07 Real-time Process
S032 2013-08-15 30-day Notice
S031 2013-03-22 30-day Notice
S030 2012-03-09 Real-time Process
S029 2011-11-18 30-day Notice
S028 2011-08-15 30-day Notice
S027 2011-02-01 30-day Notice
S026 2010-07-21 Real-time Process
S025 2010-01-07 30-day Notice
S023 2008-04-04 Normal 180 Day Track No User Fee
S021 2006-09-18 30-day Notice
S020 2005-06-24 Normal 180 Day Track No User Fee
S019 2003-08-26 Normal 180 Day Track No User Fee
S018 2003-07-25 Real-time Process
S017 1998-08-28 Normal 180 Day Track
S016 1996-03-04 Real-time Process
S015 1995-09-01 Normal 180 Day Track
S014 1995-04-11 Normal 180 Day Track
S013 1993-09-15 Normal 180 Day Track
S012 1993-04-28 Normal 180 Day Track
S011 1989-06-16 Normal 180 Day Track
S010 1989-03-13 Normal 180 Day Track
S008 1987-07-31 Normal 180 Day Track
S007 1987-03-19 Normal 180 Day Track
S006 1986-03-13
S005 1982-03-29
S003 1981-08-11
S002 1980-11-18
S001 1979-06-27


Device IDPMASupp
20705031237510 N12159 047

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