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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYLAFORM (HYLAN B GEL); PREVELLE SILK
Generic NameImplant, dermal, for aesthetic use
ApplicantGENZYME BIOSURGERY
55 CAMBRIDGE PARKWAY
CAMBRIDGE, MA 02142
PMA NumberP030032
Supplement NumberS012
Date Received05/27/2011
Decision Date07/18/2011
Withdrawal Date 02/10/2016
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
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 SPECIFICATIONFROM 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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