Dressing, Wound And Burn, Interactive
Basic Information
- Device Name
- Dressing, Wound And Burn, Interactive
- Trade Name
- DERMAGRAFT-TC(TM)
- PMA Number
- P960007
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MGR
- Generic Name
- Dressing, wound and burn, interactive
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 5, 1999
- Date Received
- November 24, 1997
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Other
- Expedited Review
- N
Advisory Committee 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 postapproval protocol for a multi-center study utilizing a within patient comparison of Dermagraft-TC (TransCyte) to a control treatment for 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. Included in this submission was to be a sample size justification for the number of patients to be evaluated. The endpoints of this study were also to include evaluation of infection rates and rate of patients who go on to require autografting.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MGR | Dressing, Wound And Burn, Interactive | FDA class 3 | Unknown |