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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 GELS
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant,dermal for aesthetic use
ApplicantMEDICIS AESTHETICS HOLDINGS,INC.
PMA NumberP040024
Supplement NumberS035
Date Received02/11/2009
Decision Date03/05/2009
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes as follows: 1) add a new raw material supplier; 2) change the site for raw material quality assurance testing to q-med ab; 3) add a heavy metals test for raw materials; and 4) modify a test method for the quality control of the finished product.
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