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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.
 
DeviceHYLAFORM PLUS (HYLAN B GEL)
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
GENZYME BIOSURGERY
55 cambridge parkway
cambridge, MA 02142
PMA NumberP030032
Supplement NumberS001
Date Received06/22/2004
Decision Date10/13/2004
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 04M-0467
Notice Date 10/27/2004
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the hylaform plus. 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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