DERMAGRAFT-TC(TM)
FDA premarket approval P960007/S005 · decided 1998-02-12
Approval details
- PMA number
- P960007
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DERMAGRAFT-TC(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1997-10-29
- Decision date
- 1998-02-12
- Days to decision
- 106 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 manufacturing to automate the cell expansion process used to prepare the fibroblast cells for inoculation into the Dermagraft-TC growth system.
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