Approval for a minor change in labeling instructions to include mixing gelfoam powder with diluents of saline for injection or thrombin. No other change included in this approval order. The device along with the modified labeling will be marketed under the trade name gelfoam absorbable gelatin powder: is intended as a hemostatic device for surgical procedures when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Although not necessary, gelfoam sterile powder can be used either with or without thrombin to obtain hemostasis.
| Device | GELFOAM (ABSORABLE GELATIN) POWDER, USP |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | PFIZER, INC. |
| Date Received | 2012-11-26 |
| Decision Date | 2013-01-07 |
| PMA | N18286 |
| Supplement | S024 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PFIZER, INC. 235 East 42nd St. new York, NY 10017 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| N18286 | | Original Filing |
| S040 |
2022-05-27 |
Special (immediate Track) |
| S039 |
2021-06-10 |
Special (immediate Track) |
| S038 |
2021-04-09 |
Special (immediate Track) |
| S037 |
2021-01-25 |
Special (immediate Track) |
| S036 |
2020-11-10 |
Special (immediate Track) |
| S035 |
2020-02-18 |
30-day Notice |
| S034 |
2020-01-29 |
30-day Notice |
| S033 |
2019-11-04 |
30-day Notice |
| S032 |
2019-06-06 |
Special (immediate Track) |
| S031 |
2018-03-12 |
30-day Notice |
| S030 |
2018-03-07 |
Normal 180 Day Track No User Fee |
| S029 |
2017-02-23 |
135 Review Track For 30-day Notice |
| S028 |
2016-04-20 |
Normal 180 Day Track |
| S027 |
2014-09-29 |
30-day Notice |
| S026 |
2014-03-12 |
30-day Notice |
| S025 |
2013-04-17 |
Special (immediate Track) |
| S024 |
2012-11-26 |
Real-time Process |
| S023 |
2011-10-13 |
Special (immediate Track) |
| S022 |
2011-09-06 |
Real-time Process |
| S021 |
2011-05-09 |
Real-time Process |
| S020 |
2010-10-12 |
Special (immediate Track) |
| S019 |
2010-03-17 |
Special (immediate Track) |
| S018 |
2009-02-26 |
Normal 180 Day Track |
| S017 |
2007-05-24 |
Normal 180 Day Track |
| S016 |
2007-04-26 |
30-day Notice |
| S015 | | |
| S014 |
2003-03-05 |
Special (immediate Track) |
| S013 |
2002-02-19 |
30-day Notice |
| S012 |
1999-12-08 |
Panel Track |
| S011 |
1999-04-05 |
Normal 180 Day Track |
| S010 |
1998-09-16 |
30-day Notice |
| S009 | | |
| S008 |
1995-04-07 |
Normal 180 Day Track |
| S007 |
1992-07-24 |
Normal 180 Day Track |
| S006 |
1991-12-24 |
Normal 180 Day Track |
| S005 |
1991-04-30 |
Normal 180 Day Track |
| S004 |
1989-11-27 |
Normal 180 Day Track |
| S003 |
1989-03-23 |
Normal 180 Day Track |
| S002 | | |
| S001 | | |
NIH GUDID Devices