DERMAGRAFT
FDA premarket approval P000036/S002 · decided 2002-03-19
Approval details
- PMA number
- P000036
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DERMAGRAFT
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2002-03-05
- Decision date
- 2002-03-19
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- 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."
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