This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | (Gelfoam (absorbable gelatin) Sterile Sponge) |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | PFIZER, INC.235 East 42nd St.new York, NY 10017 PMA NumberN18286 Supplement NumberS040 Date Received05/27/2022 Decision Date06/24/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-05-27 |
| Decision Date | 2022-06-24 |
| PMA | N18286 |
| Supplement | S040 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| 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 PMA NumberN18286 Supplement NumberS040 Date Received05/27/2022 Decision Date06/24/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Updating The Gelfoam Instructions For Use To Include Language On Visualization Of The Target Bleeding Site Before Application And To Update The Adverse Reactions Section To Include “duct Stenosis (such As Bile Duct Stenosis)” |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00360793410104 | N18286 | 017 |
| 00300090323011 | N18286 | 017 |
| 00300090342012 | N18286 | 017 |
| 00300090349035 | N18286 | 017 |
| 00300090353018 | N18286 | 017 |
| 00300090396053 | N18286 | 017 |
| 00300090433048 | N18286 | 017 |
| 00300091040061 | N18286 | 017 |
| 00360793310107 | N18286 | 017 |
| 00300090315085 | N18286 | 017 |
| 00300092250018 | N18286 | 028 |