Approval for a new version of vitagel where the bovine thrombin component is replaced with recombinant human thrombin. The product, as modified, will be marketed under the trade name vitagel rt and is indicated in surgical procedures (other than neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Device | VITAGEL SURGICAL HEMOSTAT |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | STRYKER CORP. |
| Date Received | 2011-10-27 |
| Decision Date | 2013-10-11 |
| PMA | P050044 |
| Supplement | S021 |
| Product Code | LMF |
| 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 | STRYKER CORP. 2825 Airview Boulevard portage, MI 49002 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050044 | | Original Filing |
| S033 |
2017-01-31 |
30-day Notice |
| S032 |
2015-06-16 |
30-day Notice |
| S031 |
2015-03-12 |
30-day Notice |
| S030 |
2015-03-12 |
30-day Notice |
| S029 |
2014-07-23 |
135 Review Track For 30-day Notice |
| S028 |
2014-03-07 |
Real-time Process |
| S027 |
2013-11-29 |
135 Review Track For 30-day Notice |
| S026 |
2013-11-14 |
Real-time Process |
| S025 |
2013-10-22 |
Normal 180 Day Track No User Fee |
| S024 |
2012-09-04 |
30-day Notice |
| S023 |
2012-08-29 |
Special (immediate Track) |
| S022 | | |
| S021 |
2011-10-27 |
Normal 180 Day Track |
| S020 | | |
| S019 |
2011-08-01 |
Normal 180 Day Track |
| S018 |
2011-06-29 |
30-day Notice |
| S017 |
2011-01-28 |
30-day Notice |
| S016 |
2011-01-18 |
Special (immediate Track) |
| S015 |
2010-11-02 |
30-day Notice |
| S014 |
2010-06-09 |
30-day Notice |
| S013 |
2010-03-05 |
30-day Notice |
| S012 |
2010-01-04 |
Normal 180 Day Track No User Fee |
| S011 |
2009-09-23 |
30-day Notice |
| S010 |
2009-09-01 |
30-day Notice |
| S009 |
2009-06-23 |
30-day Notice |
| S008 |
2008-12-29 |
30-day Notice |
| S007 |
2008-11-04 |
30-day Notice |
| S006 |
2008-10-15 |
30-day Notice |
| S005 |
2008-05-19 |
Special (immediate Track) |
| S004 |
2008-03-26 |
30-day Notice |
| S003 |
2007-11-06 |
Normal 180 Day Track No User Fee |
| S002 |
2007-11-06 |
Normal 180 Day Track No User Fee |
| S001 |
2006-08-08 |
Normal 180 Day Track |
NIH GUDID Devices