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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 NumberS046
Date Received01/31/2024
Decision Date02/27/2024
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  
implement the supplier's change to the sterilization method and minor dimensional changes for a part, the Crimp Cap P/N 3017, a cap for a material container used in subassembly manufacturing
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