PMA P960007S004

Device: DERMAGRAFT-TC(TM)
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S004
Product code: MGR
Decision date: 1998-05-12
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval for the new product label and directions for use for the new 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.

Current openFDA PMA Record#

Device: DERMAGRAFT-TC(TM)
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S004
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 1998-05-12
Decision code: APPR
Date received: 1997-10-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the new product label and directions for use for the new 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.