Change involving converting the seprafilm manufacturing area from a dedicated area to a shared area shere sterile hyaluronic acid (ha) will be produced. There will be no impact on the manufacturing processes with the proper cleaning of the three vessels. The cleaning process has been validated.
| Device | SEPRAFILM BIORESORBABLE MEMBRANE |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | GENZYME CORP. |
| Date Received | 2001-08-29 |
| Decision Date | 2001-09-28 |
| PMA | P950034 |
| Supplement | S020 |
| 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 | 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