SURGICEL Absorbable Hemostats

FDA Premarket Approval N12159 S076

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

Addition of surgicel original and nu-knit absorbable hemostats extra small (xs) and nu-knit medium (m) sized foil pouches to the upgraded final seal inspection system on the automated foiling line (g11719) at the ethicon sarl, switzerland site for the inspection of hermetically sealed foil pouches

DeviceSURGICEL Absorbable Hemostats
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantETHICON, INC.
Date Received2020-10-15
Decision Date2020-11-12
PMAN12159
SupplementS076
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
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
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20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002958 N12159 000
20705031002965 N12159 000
20705031002972 N12159 014
20705031002996 N12159 014
20705031063584 N12159 026
20705031063591 N12159 027
20705031063607 N12159 028
20705031063638 N12159 032
20705031063621 N12159 032
20705031063614 N12159 032
20705031005195 N12159 032
20705031005218 N12159 032
20705031005201 N12159 032
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20705031237510 N12159 047
20705031237510 N12159 047
20705031237510 N12159 047
20705031237510 N12159 047
20705031237510 N12159 047

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