Approval for a change in some of the components contained in the gelfoam plus kit as well as the introduction of an alternative gelfoam plus kit gelfoam plus compressed. The component changes will substitute prefilled saline syringes and a needleless transfer device for the standard saline vials and needle-syringe. The components have been cleared/ approved previously. The purpose of the gelfoam plus kit is to provide the convenience of co-packaged collagen sponge, saline diluent and human thrombin to a physician during surgery.
| Device | GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | PFIZER, INC. |
| Date Received | 2011-05-09 |
| Decision Date | 2011-07-09 |
| PMA | N18286 |
| Supplement | S021 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| 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