- Device
- TRANSCYTE, HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S020
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2011-06-13
- Decision code
- APPR
- Date received
- 2010-11-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE AUTOMATED AND MANUAL CELL EXPANSION TRYPSINIZATION PROCESSES FOR MANUFACTURING TRANSCYTE.