|
Device | ORCEL BILAYERED CELLULAR MATRIX |
Generic Name | Dressing, wound and burn, interactive |
Applicant | FORTICELL BIOSCIENCE 3960 BROADWAY NEW YORK, NY 10032 |
PMA Number | P010016 |
Date Received | 03/05/2001 |
Decision Date | 08/31/2001 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Docket Number | 01M-0413 |
Notice Date | 09/20/2001 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S002 |