TRANSCYTE
FDA premarket approval P960007/S017 · decided 2004-06-28
Approval details
- PMA number
- P960007
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TRANSCYTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2002-08-22
- Decision date
- 2004-06-28
- Days to decision
- 676 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE TERMINATION OF THE POST-APPROVAL STUDY PROTOCOL ENTITLE: "A RANDOMIZED, CONTROLLED WITHIN-PATIENT-PAIRED STUDY TO COMPARE THE EFFECTIVENESS OF TRANSCYTE AND BIOBRANE IN THE TREATMENT OF MID-DERMAL TO INDETERMINATE DEPTH BURN WOUNDS."
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