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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
ApplicantTiger Aesthetics Medical, LLC
555 E. N. Ln. Suite 5000, Bldg. D
Conshohocken, PA 19428
PMA NumberP020012
Supplement NumberS033
Date Received06/14/2019
Decision Date12/13/2019
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to implement a change in raw material specifications for Sodium Hydroxide
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