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.
Qualification of additional seeding vessels, and proposed a change in the type of material used for the tubing and manifold assembly connector fittings.
| Device | DERMAGRAFT (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE) |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 2013-04-24 |
| Decision Date | 2013-05-23 |
| PMA | P000036 |
| Supplement | S017 |
| Product Code | MGR |
| 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 | SHIRE REGENERATIVE MEDICINE 11095 Torreyana Road san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000036 | Original Filing | |
| S018 | 2013-04-25 | 30-day Notice |
| S017 | 2013-04-24 | 30-day Notice |
| S016 | 2013-04-23 | 30-day Notice |
| S015 | ||
| S014 | 2012-12-21 | 135 Review Track For 30-day Notice |
| S013 | 2012-06-29 | 30-day Notice |
| S012 | 2012-06-05 | 30-day Notice |
| S011 | 2012-04-23 | 135 Review Track For 30-day Notice |
| S010 | 2012-03-16 | 30-day Notice |
| S009 | 2012-03-16 | 30-day Notice |
| S008 | 2012-03-13 | Normal 180 Day Track No User Fee |
| S007 | 2010-03-02 | 30-day Notice |
| S006 | 2008-10-31 | 30-day Notice |
| S005 | ||
| S004 | ||
| S003 | 2003-11-17 | Special (immediate Track) |
| S002 | 2002-03-05 | Special (immediate Track) |
| S001 |