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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, INC.
PMA NumberP040024
Supplement NumberS055
Date Received11/04/2011
Decision Date04/23/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following changes: 1) change to label check criteria; 2) extension of compressed air distribution in building 9 (phase 2); 3) sealing of vessels after clean out of place (cop) using steriking pouch; 4) changed sampling procedure for bioburden and bacterial endotoxins tests; 5) new siliconization and luer lock adaptor assembly processes 1ml glass syringe at bd; 6) tightening of analytical acceptance limits for ha content and gel content. Change involves modification of acceptance criteria for incoming raw material, for a critical component; 7) tightening limits for lidocaine in process control and changing from a calculated to a fixed amount of added water for injection (wfi); and 8) installation of new differential pressure sensors.
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