GYNECARE INTERCEED™ Absorbable Adhesion Barrier

FDA Premarket Approval P880047 S045

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

Changes to the sampling frequency of bacterial endotoxin test (bet) lot release testing of the gynecare interceed absorbable adhesion barrier device, manufactured at ethicon sarl, from 100% batch release testing to audit testing on a monthly basis

DeviceGYNECARE INTERCEED™ Absorbable Adhesion Barrier
Generic NameBarrier, Absorbable, Adhesion
ApplicantETHICON, INC.
Date Received2021-09-29
Decision Date2021-10-29
Product CodeMCN 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ETHICON, INC. route 22 West p.o. Box 151 somerville, NJ 08876-0151

Supplemental Filings

Supplement NumberDateSupplement Type
P880047Original Filing
S045 2021-09-29 30-day Notice
S044 2021-09-22 30-day Notice
S042 2021-08-12 30-day Notice
S041 2021-08-02 30-day Notice
S040 2021-03-24 Special (immediate Track)
S039 2021-03-03 30-day Notice
S038 2020-10-06 30-day Notice
S037 2020-06-15 30-day Notice
S036 2020-04-22 30-day Notice
S035 2020-04-20 30-day Notice
S034 2020-01-03 30-day Notice
S033 2019-11-04 30-day Notice
S032 2019-06-24 30-day Notice
S031 2019-03-14 30-day Notice
S029 2019-02-05 30-day Notice
S028 2018-12-07 Special (immediate Track)
S027 2017-06-12 30-day Notice
S026 2017-03-03 30-day Notice
S025 2016-09-26 Special (immediate Track)
S024 2016-08-29 30-day Notice
S023 2016-08-26 Special (immediate Track)
S022 2016-05-19 135 Review Track For 30-day Notice
S021 2015-06-19 30-day Notice
S020 2013-02-07 30-day Notice
S019 2012-03-14 30-day Notice
S018 2011-11-16 30-day Notice
S017 2011-07-20 30-day Notice
S016 2011-06-06 30-day Notice
S015 2011-04-18 Real-time Process
S014 2011-02-01 30-day Notice
S013 2009-05-06 30-day Notice
S012 2008-04-22 Normal 180 Day Track No User Fee
S011 2006-10-25 30-day Notice
S010 2006-02-28 Normal 180 Day Track
S009 2005-06-24 Normal 180 Day Track No User Fee
S008 2003-09-04 Normal 180 Day Track No User Fee
S007 1998-12-22 Normal 180 Day Track
S006 1998-08-28 Normal 180 Day Track
S005 1997-12-03 Normal 180 Day Track
S004 1995-09-05 Special (immediate Track)
S003 1993-11-03 Normal 180 Day Track
S001 1990-03-09 Normal 180 Day Track


Device IDPMASupp
20705031147840 P880047 000
20705031005393 P880047 020

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