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 that the atp assay be used in place of the mtt assay as a means of monitoring and predicting product characteristics. The product release criteria of the atp assay stipulate that production lots of transcyte will be harvested between incubation days 12 to 16 and must have an atp value in the range of 0. 083 to 0. 127 moles per bioreactor to be considered an acceptable lot.
| Device | TRANSCYTE (DERMAGRAFT-TC) |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 1998-07-24 |
| Decision Date | 1998-12-01 |
| PMA | P960007 |
| Supplement | S009 |
| Product Code | MGR |
| 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 | 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 |