PMA P020012S021

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S021
Product code
LMH
Decision date
2018-08-27
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for a new microplate reader for endotoxin testing.

Current openFDA PMA Record#

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S021
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2018-08-27
Decision code
APPR
Date received
2018-03-05
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a new microplate reader for endotoxin testing.