TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
FDA premarket approval P960007/S015 · decided 2001-08-30
Approval details
- PMA number
- P960007
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2001-06-26
- Decision date
- 2001-08-30
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR AMENDED LABELING TO INCLUDE INFORMATION REGARDING THE RESULTS OF TESTING THE DONOR MOTHER'S SERA FOR VIRUSES AND OTHER INFECTIOUS AGENTS.
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