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 08869 PMA NumberP880047 Supplement NumberS052 Date Received11/21/2022 Decision Date12/20/2022 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 | 2022-11-21 |
| Decision Date | 2022-12-20 |
| PMA | P880047 |
| Supplement | S052 |
| 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 08869 PMA NumberP880047 Supplement NumberS052 Date Received11/21/2022 Decision Date12/20/2022 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 changes Related To Improvements To The Splice Detection, Vision System, And Reject Mechanism Of The Automated Foil Sealer Equipment (SL1099) Used To Seal The Foil Pouches At The ETHICON LLC, San Lorenzo, Puerto Rico Manufacturing Site |
| 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 |