Approval for revision of product labeling to update information that is to be provided to patients and physicians about the risks associated with use of seprafilm®. The revisions include contraindication statements regarding use of seprafilm® in patients with a history of hypersensitivity to seprafilm® and against use of seprafilm® being wrapped directly around a fresh anastomotic suture or staple line. Additional product labeling includes new warnings regarding the use of seprafilm® in patients with infections in the abdominopelvic cavity, patients with abdominopelvic malignancies, the placement of seprafilm® in locations other than directly associated with the surgical incision lines, use in patients with ongoing local and/or systemic inflammatory cell responses, seprafilm® use in the presence of other implants, and use in patients requiring re-operation within a 4 week, post-operative period. Furthermore, the change of a current precaution to a warning regarding potential foreign body reactions to seprafilm® was identified. Finally, the current precaution noting that safety and effectiveness information for use of seprafilm® in pregnant women has been revised to specifically include pregnant patients undergoing cesarean section surgical procedures.
| Device | SEPRAFILM ADHESION BARRIER |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | GENZYME CORP. |
| Date Received | 2016-12-23 |
| Decision Date | 2017-06-29 |
| PMA | P950034 |
| Supplement | S047 |
| Product Code | MCN |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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