Approval for revised cellpaker manufacture by special team medical services (yorba linda, california), terminal sterilization of the cellpaker by sterigenics us, inc. (san diego, california), and change in contractor performing the limulus amebocyte lysate assay to lexamed, ltd (toledo, ohio).
| Device | VITAGEL SURGICAL HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | STRYKER CORP. |
| Date Received | 2006-08-08 |
| Decision Date | 2007-01-25 |
| PMA | P050044 |
| Supplement | S001 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| 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