PMA P960007S006
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S006
- Product code
- MGR
- Decision date
- 1999-08-05
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order 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.
Current openFDA PMA Record#
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S006
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-08-05
- Decision code
- APPR
- Date received
- 1997-11-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order 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.