This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Change in shelf life.
| Device | VITAGEL SURGICAL HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | STRYKER CORP. |
| Date Received | 2009-09-01 |
| Decision Date | 2009-10-01 |
| PMA | P050044 |
| Supplement | S010 |
| 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 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 30808232000819 | P050044 | 000 |
| 30808232000802 | P050044 | 000 |
| 30808232001243 | P050044 | 019 |
| 00808232001280 | P050044 | 021 |
| 00808232001273 | P050044 | 021 |
| 30808232001397 | P050044 | 028 |
| 30808232001380 | P050044 | 028 |