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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 NumberS026
Date Received06/27/2008
Decision Date07/15/2008
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the following changes to the product specifications for the phosphate buffer concentrate: 1) to narrow the specification limit for the concentration of the buffering ions in the phosphate buffer to 23. 4 ¿ 28. 4 mg/ml for the potassium dihydrogen phosphate content and to 131-157 mg/ml for the disodium hydrogen phosphate content; 2) to add the bacterial endotoxin test to the phosphate buffer concentrate specification; and 3) to add the ph test to the phosphate buffer specification.
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