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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.
 
DevicePREVELLE SILK
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
GENZYME BIOSURGERY
55 cambridge parkway
cambridge, MA 02142
PMA NumberP030032
Supplement NumberS010
Date Received06/09/2010
Decision Date09/15/2010
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
P940015/s0199/15/10135-day synvisc/synvisc-one and prevelle silk genzyme biosurgerycambridge, ma02142 approval for a manufacturing change involving installation of the waters empower 2 chromatography data system.
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