PMA P000036S002

Device: DERMAGRAFT
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S002
Product code: MGR
Decision date: 2002-03-19
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR A CHANGE IN THE CAUTION STATEMENT IN THE DIRECTIONS FOR USE FROM "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE" TO "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE INDICATED ON THE LABELED UNIT CARTON."

Current openFDA PMA Record#

Device: DERMAGRAFT
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S002
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2002-03-19
Decision code: APPR
Date received: 2002-03-05
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE IN THE CAUTION STATEMENT IN THE DIRECTIONS FOR USE FROM "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE" TO "DO NOT USE DERMAGRAFT AFTER THE EXPIRATION DATE INDICATED ON THE LABELED UNIT CARTON."