Approval for a new configuration (hemorrhoidectomy sponge) of the absorbable gelatin sponge, usp as well as a new bubble wrap package, a change in the sterilization procedure involving the use of e-beam sterilization, and some minor changes to the package labeling. The device, as modified, will be marketed under the trade name surgifoam(r) absorba le gelatin sponge, usp, hemorrhoidectomy sponge and is indicated for surgical procedures (except urologic and ophthalmic) 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 HEMORRHOIDECTOMY SPONGE |
| Applicant | FERROSAN MEDICAL DEVICES A/S |
| Date Received | 2000-10-02 |
| Decision Date | 2000-11-15 |
| PMA | P990004 |
| Supplement | S003 |
| 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 | FERROSAN MEDICAL DEVICES A/S p.o. Box 151 Route 22 West somerville, NJ 08876 |
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