Change to the bacterial endotoxin test method for gelfoam absorbable gelatin sponge and gelfilm sterile film in order to comply with the recently harmonized usp, ep and jp compendia for bacterial endotoxin assay.
| Device | GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | PFIZER, INC. |
| Date Received | 2002-02-19 |
| Decision Date | 2002-03-20 |
| PMA | N18286 |
| Supplement | S013 |
| Product Code | LMF |
| 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 | 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