Approval for a change to the pallet configuration for the ethylene oxide sterilization of the thrombin kit package which is a part of the surgiflo hemostatic matrix kit with thrombin.
| Device | SURGIFLO Hemostatic Matrix Kit w/Thrombin |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | FERROSAN MEDICAL DEVICES A/S |
| Date Received | 2018-09-05 |
| Decision Date | 2019-02-20 |
| PMA | P990004 |
| Supplement | S033 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | FERROSAN MEDICAL DEVICES A/S p.o. Box 151 Route 22 West somerville, NJ 08876 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990004 | | Original Filing |
| S056 |
2022-07-01 |
135 Review Track For 30-day Notice |
| S055 |
2022-06-27 |
135 Review Track For 30-day Notice |
| S054 |
2022-03-07 |
30-day Notice |
| S053 |
2021-12-23 |
30-day Notice |
| S052 |
2021-12-20 |
30-day Notice |
| S051 |
2021-11-22 |
30-day Notice |
| S050 |
2021-09-28 |
30-day Notice |
| S049 |
2021-07-26 |
Special (immediate Track) |
| S048 |
2021-05-03 |
30-day Notice |
| S047 |
2021-04-02 |
30-day Notice |
| S046 | | |
| S045 | | |
| S044 | | |
| S043 |
2020-08-26 |
30-day Notice |
| S042 |
2020-07-30 |
Special (immediate Track) |
| S041 |
2020-06-24 |
30-day Notice |
| S040 |
2020-06-08 |
30-day Notice |
| S039 | | |
| S038 |
2020-03-19 |
30-day Notice |
| S037 |
2020-02-18 |
30-day Notice |
| S036 |
2019-10-01 |
Special (immediate Track) |
| S035 |
2019-02-04 |
135 Review Track For 30-day Notice |
| S034 | | |
| S033 |
2018-09-05 |
135 Review Track For 30-day Notice |
| S032 |
2017-08-25 |
30-day Notice |
| S031 |
2017-05-04 |
30-day Notice |
| S030 |
2017-02-09 |
30-day Notice |
| S029 |
2016-01-27 |
30-day Notice |
| S028 |
2015-03-06 |
Normal 180 Day Track No User Fee |
| S027 |
2015-02-18 |
30-day Notice |
| S026 |
2015-02-18 |
30-day Notice |
| S025 |
2014-10-24 |
Normal 180 Day Track |
| S024 |
2014-04-22 |
Normal 180 Day Track No User Fee |
| S023 |
2012-10-22 |
135 Review Track For 30-day Notice |
| S022 |
2012-06-18 |
Special (immediate Track) |
| S021 |
2011-02-04 |
30-day Notice |
| S020 | | |
| S019 |
2010-10-18 |
Normal 180 Day Track |
| S018 |
2010-06-23 |
Real-time Process |
| S017 |
2010-03-02 |
Real-time Process |
| S016 |
2009-07-06 |
Real-time Process |
| S015 |
2008-09-03 |
30-day Notice |
| S014 |
2008-06-27 |
30-day Notice |
| S013 |
2007-07-05 |
Normal 180 Day Track |
| S012 |
2007-06-20 |
Normal 180 Day Track |
| S011 |
2007-03-19 |
Real-time Process |
| S010 |
2006-08-30 |
Real-time Process |
| S009 |
2005-12-20 |
Real-time Process |
| S008 |
2005-03-10 |
Real-time Process |
| S007 |
2004-11-16 |
Normal 180 Day Track No User Fee |
| S006 |
2004-05-10 |
Real-time Process |
| S005 |
2004-01-26 |
Normal 180 Day Track No User Fee |
| S004 |
2002-08-23 |
Real-time Process |
| S003 |
2000-10-02 |
Real-time Process |
| S002 |
1999-11-16 |
Real-time Process |
| S001 |
1999-11-15 |
Real-time Process |
NIH GUDID Devices