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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 NumberS015
Date Received09/01/2017
Decision Date09/28/2017
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  
Removal of redundant quality control tests for SAN 8250 In-Process Tests with respect to PMMA.
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