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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 PHARMACEUTICAL CORP.
PMA NumberP040024
Supplement NumberS041
Date Received06/10/2009
Decision Date07/10/2009
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 in sanitation criteria for water for injection (wfi), reduction of water sampling for purified water (pw) and wfi, and reduction of frequency of periodic review of utility systems.
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