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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 NumberS047
Date Received03/29/2024
Decision Date04/26/2024
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to implement an alternate shipper (shipping container).
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