DERMAGRAFT
FDA premarket approval P000036/S014 · decided 2013-02-28
Approval details
- PMA number
- P000036
- Supplement
- S014
- 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
- 2012-12-21
- Decision date
- 2013-02-28
- Days to decision
- 69 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 INTRA-UNIT SAMPLING REGIMEN FOR DERMAGRAFT ANALYTICAL RELEASE ASSAYS.
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