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 to conduct the final product sterility test in-house under the conditions of an isolator environment.
| Device | TRANSCYTE(TM) |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 2000-03-01 |
| Decision Date | 2000-05-19 |
| PMA | P960007 |
| Supplement | S014 |
| Product Code | MGR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |