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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 Filter
Generic Nameimplant, dermal, for aesthetic use
ApplicantSUNEVA MEDICAL, INC.
5879 pacific center blvd.
san diego, CA 92121
PMA NumberP020012
Supplement NumberS013
Date Received03/06/2017
Decision Date04/06/2017
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  
1) Changed contract test lab and associated SOP for residual monomer in unprocessed PMMA microspheres; 2) Changed contract test lab and associated SOP for residual monomer in processed non-sterile PMMA microspheres; and 3) Added reference to internal manufacturing document and clarified rejectcriteria for finished product specification.
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