ORCEL BILAYERED CELLULAR MATRIX
FDA premarket approval P010016/S002 · decided 2002-01-17
Approval details
- PMA number
- P010016
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Trade name
- ORCEL BILAYERED CELLULAR MATRIX
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Forticell Bioscience
- Date received
- 2001-12-27
- Decision date
- 2002-01-17
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR USE OF CELL LINE FS-183 IN THE COMMERCIAL MANUFACTURE OF ORCEL BILAYERED CELLULAR MATRIX.
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