DERMAGRAFT
FDA premarket approval P000036/S011 · decided 2012-09-05
Approval details
- PMA number
- P000036
- Supplement
- S011
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DERMAGRAFT
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2012-04-23
- Decision date
- 2012-09-05
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE QUALIFICATION OF AN ALTERNATE SUPPLIER FOR A CRITICAL DEVICE COMPONENT.
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