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 | Seprafilm Adhesion Barrier |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | Baxter Healthcare Corporationone Baxter Parkwaydeerfield, IL 60015 PMA NumberP950034 Supplement NumberS055 Date Received11/23/2022 Decision Date12/22/2022 Product Code MCN Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-23 |
| Decision Date | 2022-12-22 |
| PMA | P950034 |
| Supplement | S055 |
| Product Code | MCN |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Baxter Healthcare Corporation one Baxter Parkway deerfield, IL 60015 PMA NumberP950034 Supplement NumberS055 Date Received11/23/2022 Decision Date12/22/2022 Product Code MCN Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Removal Of An In-Process Control As Part Of The Seprafilm Packaging Process Of Counting Films |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950034 | Original Filing | |
| S055 | 2022-11-23 | 30-day Notice |
| S054 | ||
| S053 | 2021-05-11 | 30-day Notice |
| S052 | 2021-03-05 | 30-day Notice |
| S051 | ||
| S050 | 2018-02-08 | 30-day Notice |
| S049 | 2017-09-27 | 30-day Notice |
| S048 | 2017-08-04 | 30-day Notice |
| S047 | 2016-12-23 | Special (immediate Track) |
| S046 | 2016-10-18 | 30-day Notice |
| S045 | 2015-12-15 | 30-day Notice |
| S044 | 2015-12-10 | 30-day Notice |
| S043 | 2015-10-29 | 30-day Notice |
| S042 | 2014-07-14 | 30-day Notice |
| S041 | 2012-02-16 | Normal 180 Day Track No User Fee |
| S040 | 2011-06-13 | 135 Review Track For 30-day Notice |
| S039 | 2010-12-10 | 30-day Notice |
| S038 | 2010-11-22 | 30-day Notice |
| S037 | 2010-10-29 | Real-time Process |
| S036 | 2010-10-08 | 30-day Notice |
| S035 | 2010-09-27 | 30-day Notice |
| S034 | 2010-09-07 | 30-day Notice |
| S033 | 2010-08-16 | 30-day Notice |
| S032 | 2009-11-02 | 30-day Notice |
| S031 | 2008-06-09 | Special (immediate Track) |
| S030 | ||
| S029 | ||
| S028 | 2005-11-18 | 30-day Notice |
| S027 | 2005-01-06 | Normal 180 Day Track No User Fee |
| S026 | 2003-08-05 | Real-time Process |
| S025 | 2003-04-30 | 30-day Notice |
| S024 | 2003-03-27 | 30-day Notice |
| S023 | 2003-02-25 | 30-day Notice |
| S022 | 2002-09-24 | Real-time Process |
| S021 | 2002-03-01 | 30-day Notice |
| S020 | 2001-08-29 | 30-day Notice |
| S019 | ||
| S018 | 2001-08-20 | Real-time Process |
| S017 | 2000-11-28 | Real-time Process |
| S016 | 2000-05-30 | Real-time Process |
| S015 | 2000-05-24 | 30-day Notice |
| S014 | 2000-02-18 | Real-time Process |
| S013 | 1999-08-09 | 30-day Notice |
| S012 | 1999-08-03 | 30-day Notice |
| S011 | 1999-02-11 | Real-time Process |
| S010 | 1998-12-22 | 30-day Notice |
| S009 | ||
| S008 | 1998-01-28 | Real-time Process |
| S007 | 1997-08-19 | Normal 180 Day Track |
| S006 | 1997-06-02 | Real-time Process |
| S005 | 1997-04-16 | Real-time Process |
| S004 | ||
| S003 | 1996-11-22 | Real-time Process |
| S002 | 1996-11-18 | Normal 180 Day Track |
| S001 | 1996-10-22 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00358468664211 | P950034 | 000 |
| 35413765589622 | P950034 | 000 |
| 35413765589639 | P950034 | 000 |
| 35413765589646 | P950034 | 000 |
| 35413765589653 | P950034 | 000 |
| 00358468430120 | P950034 | 000 |
| 00358468664112 | P950034 | 000 |
| 35413765589615 | P950034 | 000 |
| 00358468508621 | P950034 | 017 |
| 00358468638014 | P950034 | 037 |