DERMAGRAFT-TC(TM)
FDA premarket approval P960007/S006 · decided 1999-08-05
Approval details
- PMA number
- P960007
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- DERMAGRAFT-TC(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1997-11-24
- Decision date
- 1999-08-05
- Days to decision
- 619 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for "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." This study addresses one of the Conditions of Approval in the October 17, 1997 Agency letter for the indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. The condition was for a p
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