ORCEL BILAYERED CELLULAR MATRIX
FDA premarket approval P010016 · decided 2001-08-31
Approval details
- PMA number
- P010016
- Trade name
- ORCEL BILAYERED CELLULAR MATRIX
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Forticell Bioscience
- Date received
- 2001-03-05
- Decision date
- 2001-08-31
- Days to decision
- 179 days
- Decision code
- APCV
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR THE ORCE BILAYERED CELLULAR MATRIX. THE DEVICE IS INDICATED FOR THE TREATMENT OF FRESH, CLEAN SPLIT THICKNESS DONOR SITE WOUNDS IN BURN PATIENTS.
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