PMA P960007S007
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S007
- Product code
- MGR
- Decision date
- 1998-05-29
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval for a post approval study assessing the incidence of burn wound infection in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require such a covering prior to autograft placement.
Current openFDA PMA Record#
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S007
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1998-05-29
- Decision code
- APPR
- Date received
- 1998-01-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- Approval for a post approval study assessing the incidence of burn wound infection in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require such a covering prior to autograft placement.