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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.
 
DeviceBellafill Dermal Filler
Generic NameImplant, dermal, for aesthetic use
ApplicantSUNEVA MEDICAL, INC.
5879 PACIFIC CENTER BLVD.
SAN DIEGO, CA 92121
PMA NumberP020012
Supplement NumberS036
Date Received05/22/2020
Decision Date06/19/2020
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a revision to the clinician labeling of Bellafill Dermal Filler to include updated safety information based upon post marketing surveillance data.
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