GYNECARE INTERCEED Absorbable Adhesion Barrier

FDA Premarket Approval P880047 S037

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

Change of the endotoxin testing services provider

DeviceGYNECARE INTERCEED Absorbable Adhesion Barrier
Generic NameBarrier, Absorbable, Adhesion
ApplicantETHICON, INC.
Date Received2020-06-15
Decision Date2020-07-15
PMAP880047
SupplementS037
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
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
S030
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
S002
S001 1990-03-09 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
20705031147840 P880047 000
20705031005393 P880047 020

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.