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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceJuvéderm Injectable Gel Implants
Generic Nameimplant, dermal, for aesthetic use
ApplicantAllergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP050047
Supplement NumberS060
Date Received05/18/2017
Decision Date05/25/2017
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of two additional equipment to support automated visual inspection of 1 mL syringes filled to 1.0 mL product configurations.
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