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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHYLAFORM (HYLAN B GEL)
Classification Nameimplant, dermal, for aesthetic use
Generic Namehylan b gel
ApplicantGENZYME BIOSURGERY
PMA NumberP030032
Date Received08/01/2003
Decision Date04/22/2004
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 04M-0199
Notice Date 05/05/2004
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the hylaform. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S012 S013 S014 
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