Approval for a larger interceed product that measures 5¿x6¿ in size. The device, as modified, is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved.
| Device | ABSORBABLE ADHESION BARRIER |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | ETHICON, INC. |
| Date Received | 2011-04-18 |
| Decision Date | 2011-06-17 |
| PMA | P880047 |
| Supplement | S015 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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