DERMAGRAFT
FDA premarket approval P000036/S008 · decided 2012-04-18
Approval details
- PMA number
- P000036
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DERMAGRAFT
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2012-03-13
- Decision date
- 2012-04-18
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT FLEXMEDICAL, IN TIJUANA, BAJA CALIFORNIA, MEXICO AND ADVANCED BIOHEALING INC., IN SAN DIEGO, CALIFORNIA.
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