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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.
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Q-Med AB
seminariegatan 21
se-752 28
uppsala SE-75-752-
PMA NumberP020023
Supplement NumberS012
Date Received06/06/2005
Decision Date10/21/2005
Product Code
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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.