SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,

FDA Premarket Approval N12159 S083

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

The addition of new and duplicate equipment to support automation of the operations and increase manufacturing capacity at the ethicon, llc, san lorenzo, puerto rico facility

DeviceSURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantETHICON, INC.
Date Received2021-08-12
Decision Date2021-09-10
PMAN12159
SupplementS083
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
S083 2021-08-12 30-day Notice
S082 2021-08-02 30-day Notice
S081 2021-07-22 30-day Notice
S080 2021-07-01 30-day Notice
S079 2021-03-03 30-day Notice
S078 2021-03-03 30-day Notice
S077 2020-11-25 30-day Notice
S076 2020-10-15 30-day Notice
S075 2020-10-06 30-day Notice
S074 2020-07-20 30-day Notice
S073
S072 2020-06-15 30-day Notice
S071
S070 2020-03-20 30-day Notice
S069
S068 2020-02-04 30-day Notice
S067 2019-11-04 30-day Notice
S066 2019-10-23 30-day Notice
S065 2019-09-30 30-day Notice
S064 2019-09-09 30-day Notice
S063
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
S057
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
S052
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)
S045
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
S024
S023 2008-04-04 Normal 180 Day Track No User Fee
S022
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
S009
S008 1987-07-31 Normal 180 Day Track
S007 1987-03-19 Normal 180 Day Track
S006 1986-03-13
S005 1982-03-29
S004
S003 1981-08-11
S002 1980-11-18
S001 1979-06-27

NIH GUDID Devices

Device IDPMASupp
20705031002958 N12159 000
20705031002965 N12159 000
20705031002996 N12159 014
20705031003016 N12159 014
20705031003023 N12159 014
20705031003061 N12159 014
20705031003030 N12159 014
20705031002972 N12159 014
20705031003122 N12159 015
20705031003115 N12159 015
20705031003139 N12159 015
20705031063584 N12159 026
20705031063591 N12159 027
20705031063607 N12159 028
20705031005355 N12159 032
20705031005195 N12159 032
20705031005201 N12159 032
20705031005218 N12159 032
20705031063614 N12159 032
20705031063621 N12159 032
20705031063638 N12159 032
20705031237510 N12159 047

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