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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 NameRESTYLANE
Classification Nameimplant, dermal, for aesthetic use
Generic Nameinjectable gel
ApplicantQ-MED SCANDINAVIA, INC.
PMA NumberP020023
Supplement NumberS008
Date Received06/22/2004
Decision Date07/23/2004
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the product box label to say "syringe contents are sterile".
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