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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, PERLANE, RESTYLANE L, PERLANE L
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant,dermal for aesthetic use
ApplicantMEDICIS-DIVISION OF VALENT PHARMACEUTICALS NORTH AMERICA LLC
PMA NumberP040024
Supplement NumberS074
Date Received05/29/2014
Decision Date06/25/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Introduction of a second supplier for ready prepared solutions used in the manufacture of the restylane injectable gels.
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