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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 AND HYLAFORM PLUS
Classification Nameimplant, dermal, for aesthetic use
Generic Namehylan b gel
ApplicantGENZYME BIOSURGERY
PMA NumberP030032
Supplement NumberS004
Date Received09/27/2005
Decision Date11/02/2005
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the hylaform and hylaform plus shelf life from 24 to 36 months.
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