Approval for the vitagel surgical hemostat. The device is indicated for use in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Device | VITAGEL RT3 SUTGICAL HEMOSTAT |
| Classification Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | STRYKER CORP. |
| Date Received | 2005-11-30 |
| Decision Date | 2006-06-16 |
| Notice Date | 2006-07-26 |
| PMA | P050044 |
| Supplement | S |
| Product Code | PMX |
| Docket Number | 06M-0293 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRYKER CORP. 2825 Airview Boulevard portage, MI 49002 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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