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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 L AND PERLANE L INJECTABLE GEL
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant,dermal for aesthetic use
ApplicantMEDICIS AESTHETICS, INC.
PMA NumberP040024
Supplement NumberS065
Date Received12/07/2012
Decision Date02/28/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the plunger rod for the 2. 25 ml syringe for restylane l and perlane l injectable gel (2 ml fill sizes).
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