Approval for revised labeling to reflect a recent study finding that laproscopic use increased adhesions compared to the control group.
| Device | INTERCEED*(TC7) ABSORBABLE ADHESION BARRIER |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | ETHICON, INC. |
| Date Received | 1998-12-22 |
| Decision Date | 1999-05-24 |
| PMA | P880047 |
| Supplement | S007 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ETHICON, INC. route 22 West p.o. Box 151 somerville, NJ 08876-0151 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P880047 | | Original Filing |
| S052 |
2022-11-21 |
30-day Notice |
| S051 | | |
| S050 |
2022-06-08 |
30-day Notice |
| S049 |
2021-12-20 |
30-day Notice |
| S048 | | |
| S047 | | |
| S046 | | |
| S045 |
2021-09-29 |
30-day Notice |
| S044 |
2021-09-22 |
30-day Notice |
| S043 | | |
| 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 |
| 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