Approval for the following changes to the ba-02 delivery system component of vitagel rt3 surgical hemostat: replacement of the current syringe clip and syringe support components with a twin syringe dispenser, replacement of the current joiner component with a rotating luer adapter (syringe adapter) to the distal luer connections of the extended applicators, changes in materials of construction and manufacturers of the aforementioned components and update in the primary packaging. Additionally, the optional extended applicator delivery accessories of the vitagel rt3 surgical hemostat, malleable extended applicator (mea) and laparoscopic extended applicator (lea), as modified, will be marketed under the trade names reach 9 malleable applicator and reach 38 laparoscopic applicator, respectively.
| Device | VITAGEL RT3 DELIVERY SYSTEM |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | STRYKER CORP. |
| Date Received | 2014-03-07 |
| Decision Date | 2014-06-05 |
| PMA | P050044 |
| Supplement | S028 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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