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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 NameCAPTIQUE INJECTABLE GEL
Classification Nameimplant, dermal, for aesthetic use
Generic Namehylan b gel
ApplicantGENZYME BIOSURGERY
PMA NumberP030032
Supplement NumberS002
Date Received08/18/2004
Decision Date11/12/2004
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new source of hyaluronic acid obtained from bacterial fermentation. The device, as modified, will be marketed under the trade name captique and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
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