DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE
FDA premarket approval P000036/S013 · decided 2012-07-23
Approval details
- PMA number
- P000036
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2012-06-29
- Decision date
- 2012-07-23
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- USAGE OF TWO ADDITIONAL VACUUM SEALERS DURING THE PACKAGING PROCESS.
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