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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 SILK SPHAL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant,dermal for aesthetic use
ApplicantMEDICIS-DIVISION OF VALENT PHARMACEUTICALS NORTH AMERICA LLC
PMA NumberP040024
Supplement NumberS072
Date Received10/22/2013
Decision Date06/13/2014
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 14M-0872
Notice Date 06/30/2014
Advisory Committee General & Plastic Surgery
Clinical Trials NCT01591369
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for restylane silk. This device is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
Approval Order Approval Order
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