Approval for a new size of seprafilm(r) and to change the name of the product from seprafilm(r) bioresorbable membrane to seprafilm(r) adhesion barrier. The labeling has been modified to reflect the new name and new size and the package insert was modified to be included with both sizes. Furthermore, the labeling has been modified to omit the reference to the clinical study in the foreign body precaution.
| Device | SEPRAFILM(R) BIORESORBABLE MEMBRAND |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | GENZYME CORP. |
| Date Received | 2000-11-28 |
| Decision Date | 2000-12-20 |
| PMA | P950034 |
| Supplement | S017 |
| Product Code | MCN |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GENZYME CORP. 52 Binney Street cambridge, MA 02142 |
Supplemental Filings
| 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 |
NIH GUDID Devices