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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 INJECTABLE GEL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant,dermal for aesthetic use
ApplicantMEDICIS AESTHETICS HOLDINGS,INC.
PMA NumberP040024
Supplement NumberS022
Date Received05/19/2008
Decision Date05/30/2008
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the introduction of a qc sample to the test method for protein content in ha raw material.
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