- Device
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S018
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2003-12-15
- Decision code
- APPR
- Date received
- 2003-11-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A DIRECT CULTURE-BASED 28-DAY PROCEDURE FOR MYCOPLASMA DETECTION BEFORE TRANCYTE MARKETING RELEASE.