Implementation of an alternative cleaning procedure for equipment and components used in the production of vitagel rt3 surgical hemostat.
| Device | VITAGEL SURGICAL HEMOSTAT (RT3) |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | STRYKER CORP. |
| Date Received | 2015-03-12 |
| Decision Date | 2015-04-14 |
| PMA | P050044 |
| Supplement | S031 |
| 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 | 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