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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHYLAFORM (HYLAN B GEL); PREVELLE SILK
Classification Nameimplant, dermal, for aesthetic use
Generic Namehylaform
ApplicantGENZYME CORP.
PMA NumberP030032
Supplement NumberS012
Date Received05/27/2011
Decision Date07/18/2011
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
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).
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