TRANSCYTE, HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
FDA premarket approval P960007/S020 · decided 2011-06-13
Approval details
- PMA number
- P960007
- Supplement
- S020
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRANSCYTE, HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2010-11-01
- Decision date
- 2011-06-13
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR MODIFICATION OF THE AUTOMATED AND MANUAL CELL EXPANSION TRYPSINIZATION PROCESSES FOR MANUFACTURING TRANSCYTE.
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