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.
Approval for the addition of a direct culture-based 28-day procedure for mycoplasma detection before trancyte marketing release.
| Device | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 2003-11-17 |
| Decision Date | 2003-12-15 |
| PMA | P960007 |
| Supplement | S018 |
| Product Code | MGR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | SHIRE REGENERATIVE MEDICINE 11095 Torreyana Road san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960007 | Original Filing | |
| S021 | 2011-03-07 | Normal 180 Day Track |
| S020 | 2010-11-01 | 135 Review Track For 30-day Notice |
| S019 | 2010-07-26 | 30-day Notice |
| S018 | 2003-11-17 | Special (immediate Track) |
| S017 | 2002-08-22 | Normal 180 Day Track No User Fee |
| S016 | 2001-11-05 | Real-time Process |
| S015 | 2001-06-26 | Normal 180 Day Track |
| S014 | 2000-03-01 | Normal 180 Day Track |
| S013 | 1999-09-02 | Normal 180 Day Track |
| S012 | ||
| S011 | 1999-08-19 | Normal 180 Day Track |
| S010 | ||
| S009 | 1998-07-24 | Normal 180 Day Track |
| S008 | 1998-07-10 | Normal 180 Day Track |
| S007 | 1998-01-09 | Normal 180 Day Track |
| S006 | 1997-11-24 | Normal 180 Day Track |
| S005 | 1997-10-29 | Normal 180 Day Track |
| S004 | 1997-10-21 | Real-time Process |
| S003 | 1997-10-22 | Normal 180 Day Track |
| S002 | 1997-05-05 | Real-time Process |
| S001 | 1997-04-08 | Real-time Process |