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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 NumberS019
Date Received03/10/2008
Decision Date04/02/2008
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of the metal analysis test used to detect impurities in new stainless steel production equipment that is used in the manufacturing of the device.
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