Approval for the addition of second sensor on the band sealing equipment that seals the open side of the foil pouch of the surgicel family of absorbable hemostats and gynecare interceed absorbable adhesion barrier products manufactured at ethicon, sarl.
| Device | GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | ETHICON, INC. |
| Date Received | 2016-08-26 |
| Decision Date | 2016-09-20 |
| PMA | P880047 |
| Supplement | S023 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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