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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 NumberS023
Date Received03/13/2018
Decision Date04/11/2018
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  
Resurrection and utilization of subassembly batch record, SAN 8004, 8th Purified Collagen Cake, for formulation in SAN 8005, 3.5% Atelocollagen with 0.3% Lidocaine, 20cc Syringe, on an as needed basis only.
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