Approval for 1)the addition of an alternate 60 denier yarn constructed of 24 filaments instead of 18 filaments, and 2) the addition of the alternate final product release site of somerville, new jersey. The device, as modified, will be marketed under the trade name interceed*(tc7) and is indicated as an adhesion barrier to be used as an adjuvant to gynecologic pelvic surgery.
| Device | INTERCEED TC7 ABSORBABLE ADHESION BARRIER |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | ETHICON, INC. |
| Date Received | 1997-12-03 |
| Decision Date | 1998-02-09 |
| PMA | P880047 |
| Supplement | S005 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| 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