PMA P020012S014

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S014
Product code
LMH
Decision date
2018-08-28
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for changes to the 1mL syringe barrel material and changes to the syringe cap design and material supplier.

Current openFDA PMA Record#

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S014
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2018-08-28
Decision code
APPR
Date received
2017-06-15
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the 1mL syringe barrel material and changes to the syringe cap design and material supplier.