TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
FDA premarket approval P960007/S016 · decided 2001-12-26
Approval details
- PMA number
- P960007
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2001-11-05
- Decision date
- 2001-12-26
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE CEASING OF ENROLLMENT OF NEW PATIENTS IN THE POST-MARKET APPROVAL STUDY: TC-01-07-0597 "AN OPEN LABEL STUDY TO EVALUATE THE INCIDENCE OF WOUND INFECTION IN PATIENTS REQUIRING A TEMPORARY COVERING FOR EXCISED BURN WOUNDS"
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