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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 PMMA COLLAGEN 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 NumberS011
Date Received02/24/2015
Decision Date08/07/2015
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00778531
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT DESCRIBED THE RESULTS OF YOUR 5-YEAR POST-APPROVAL STUDY (P521-01).
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