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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 FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)
Classification Nameimplant, dermal, for aesthetic use
Generic Namehylan b gel
ApplicantGENZYME BIOSURGERY
PMA NumberP030032
Supplement NumberS008
Date Received04/15/2009
Decision Date02/24/2010
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling update to captique as a follow-up to the post-approval study.
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