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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, INC.
PMA NumberP040024
Supplement NumberS053
Date Received07/07/2011
Decision Date01/26/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a relocation of the current quality control laboratory (qc-lab) for chemical, microbiological and receiving inspection analysis to a new location with q-med¿s existing facilities.
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