|Trade Name||HYLAFORM (HYLAN B GEL); PREVELLE SILK|
|Classification Name||implant, dermal, for aesthetic use|
||General & Plastic Surgery
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes in the methods and specifications for testing the prevelle silk final product (i. E. , 1) changing the average extrusion force specification from less than 80n to an average of average extrusion force specification of less than 40n, 2) changing the maximum peak extrusion force specification of less than 100n to an average of maximum peak extrusion force" specification of less than 50n and 3) changing the method of determining the maximum peak extrusion force specification from the highest single value observed in 10 samples to an average of the maximum peak extrusion force test results observed in 25 samples).