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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 AB
PMA NumberP020023
Supplement NumberS012
Date Received06/06/2005
Decision Date10/21/2005
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for performing the protein testing in-house at the q-med quality control laboratory and to change the test method so as to allow for the detection of lower amounts of protein. The device, as modified, will be marketed under the trade name restylane and is indicated as an injectable gel for aesthetic use.
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