PMA P960007S002
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S002
- 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 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 sucha covering prior to autograft placement.
Current openFDA PMA Record#
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S002
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1998-05-29
- Decision code
- APPR
- Date received
- 1997-05-05
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for a post approval study assessing the incidence of burn wound infection in 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 sucha covering prior to autograft placement.