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.
| Device | Gynecare Interceed Absorbable Adhesion Barrier |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | ETHICON, INC.1000 Route 202raritan, NJ 00869 PMA NumberP880047 Supplement NumberS050 Date Received06/08/2022 Decision Date07/08/2022 Product Code MCN Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-08 |
| Decision Date | 2022-07-08 |
| PMA | P880047 |
| Supplement | S050 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ETHICON, INC. 1000 Route 202 raritan, NJ 00869 PMA NumberP880047 Supplement NumberS050 Date Received06/08/2022 Decision Date07/08/2022 Product Code MCN Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval To Establish A New Slit And Cutting Room In The Ethicon LLC San Lorenzo, Puerto Rico Manufacturing Facility |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 20705031147840 | P880047 | 000 |
| 20705031005393 | P880047 | 020 |