ORCEL BILAYERED CELLULAR MATRIX
FDA premarket approval P010016/S001 · decided 2001-12-06
Approval details
- PMA number
- P010016
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORCEL BILAYERED CELLULAR MATRIX
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Forticell Bioscience
- Date received
- 2001-10-18
- Decision date
- 2001-12-06
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR THE USE OF CELL LINES FS-143 AND FS-145 IN THE COMMERCIAL MANUFACTURE OF ORCEL BILAYERED CELLULAR MATRIX.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.