Approval for the surgifoam absorbable gelatin sponge, u. S. P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
| Device | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | FERROSAN MEDICAL DEVICES A/S |
| Date Received | 1999-01-22 |
| Decision Date | 1999-09-30 |
| PMA | P990004 |
| Supplement | S |
| Product Code | LMF |
| Docket Number | 99M-4776 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FERROSAN MEDICAL DEVICES A/S p.o. Box 151 Route 22 West somerville, NJ 08876 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990004 | | Original Filing |
| S056 |
2022-07-01 |
135 Review Track For 30-day Notice |
| S055 |
2022-06-27 |
135 Review Track For 30-day Notice |
| S054 |
2022-03-07 |
30-day Notice |
| S053 |
2021-12-23 |
30-day Notice |
| S052 |
2021-12-20 |
30-day Notice |
| S051 |
2021-11-22 |
30-day Notice |
| S050 |
2021-09-28 |
30-day Notice |
| S049 |
2021-07-26 |
Special (immediate Track) |
| S048 |
2021-05-03 |
30-day Notice |
| S047 |
2021-04-02 |
30-day Notice |
| S046 | | |
| S045 | | |
| S044 | | |
| S043 |
2020-08-26 |
30-day Notice |
| S042 |
2020-07-30 |
Special (immediate Track) |
| S041 |
2020-06-24 |
30-day Notice |
| S040 |
2020-06-08 |
30-day Notice |
| S039 | | |
| S038 |
2020-03-19 |
30-day Notice |
| S037 |
2020-02-18 |
30-day Notice |
| S036 |
2019-10-01 |
Special (immediate Track) |
| S035 |
2019-02-04 |
135 Review Track For 30-day Notice |
| S034 | | |
| S033 |
2018-09-05 |
135 Review Track For 30-day Notice |
| S032 |
2017-08-25 |
30-day Notice |
| S031 |
2017-05-04 |
30-day Notice |
| S030 |
2017-02-09 |
30-day Notice |
| S029 |
2016-01-27 |
30-day Notice |
| S028 |
2015-03-06 |
Normal 180 Day Track No User Fee |
| S027 |
2015-02-18 |
30-day Notice |
| S026 |
2015-02-18 |
30-day Notice |
| S025 |
2014-10-24 |
Normal 180 Day Track |
| S024 |
2014-04-22 |
Normal 180 Day Track No User Fee |
| S023 |
2012-10-22 |
135 Review Track For 30-day Notice |
| S022 |
2012-06-18 |
Special (immediate Track) |
| S021 |
2011-02-04 |
30-day Notice |
| S020 | | |
| S019 |
2010-10-18 |
Normal 180 Day Track |
| S018 |
2010-06-23 |
Real-time Process |
| S017 |
2010-03-02 |
Real-time Process |
| S016 |
2009-07-06 |
Real-time Process |
| S015 |
2008-09-03 |
30-day Notice |
| S014 |
2008-06-27 |
30-day Notice |
| S013 |
2007-07-05 |
Normal 180 Day Track |
| S012 |
2007-06-20 |
Normal 180 Day Track |
| S011 |
2007-03-19 |
Real-time Process |
| S010 |
2006-08-30 |
Real-time Process |
| S009 |
2005-12-20 |
Real-time Process |
| S008 |
2005-03-10 |
Real-time Process |
| S007 |
2004-11-16 |
Normal 180 Day Track No User Fee |
| S006 |
2004-05-10 |
Real-time Process |
| S005 |
2004-01-26 |
Normal 180 Day Track No User Fee |
| S004 |
2002-08-23 |
Real-time Process |
| S003 |
2000-10-02 |
Real-time Process |
| S002 |
1999-11-16 |
Real-time Process |
| S001 |
1999-11-15 |
Real-time Process |
NIH GUDID Devices