FDA.reportPublic FDA data

PMA P020012S036

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S036
Product code
LMH
Decision date
2020-06-19
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for a revision to the clinician labeling of Bellafill Dermal Filler to include updated safety information based upon post marketing surveillance data.

Current openFDA PMA Record#

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S036
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-06-19
Decision code
APPR
Date received
2020-05-22
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a revision to the clinician labeling of Bellafill Dermal Filler to include updated safety information based upon post marketing surveillance data.