The 30-day notice request the addition of a new packaging machine (doyen) to package/seal the outer envelope (primary sterile barrier) of the gelforam(r) sterile sponge. The addition of the new packaging machine resulted in other hcange that included a new paper vendor and a change in the application of the adhesive pattern on the package. The label copy will be printe don line and no longer supplied by the paper vendor; and the smallest gelfoam(r) package size, 12-7 (3"x71/2") was changed to 4"x71/2" due to limitations of the doyen packaging machine. As a result of this packaging size change, the sterilization process was validated successfully. A uv decontamination procedure was also incorporated into the standard operating procedure for container closure integrity testing to minimize the risk of th false-positive results during sterility testing. The added packaging equipment will be used as the primary packaging line, while the ucrrent packaging equipment (circle) will be used as an alternate.
| Device | GELFOAM STERILE SPONGE |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | PFIZER, INC. |
| Date Received | 1998-09-16 |
| Decision Date | 1998-10-14 |
| PMA | N18286 |
| Supplement | S010 |
| 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