Approval for a packaging change to introduce a new packaging configuration for the thrombin kit package for surgiflo hemostatic matrix kit with thrombin. This change was requested for the manufacturing site located at steripack medical poland sp. Zo. O. , poland, for the contract packaging of the surgiflo hemostatic matrix device and the sterilizing site located at synergy health ede bv, netherlands, for the sterilization of the surgiflo hemostatic matrix device.
| Device | SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | FERROSAN MEDICAL DEVICES A/S |
| Date Received | 2014-10-24 |
| Decision Date | 2016-05-16 |
| PMA | P990004 |
| Supplement | S025 |
| Product Code | LMF |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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