FDA.reportPublic FDA data

PMA P020012S023

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S023
Product code
LMH
Decision date
2018-04-11
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Resurrection and utilization of subassembly batch record, SAN 8004, 8th Purified Collagen Cake, for formulation in SAN 8005, 3.5% Atelocollagen with 0.3% Lidocaine, 20cc Syringe, on an as needed basis only.

Current openFDA PMA Record#

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S023
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2018-04-11
Decision code
OK30
Date received
2018-03-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Resurrection and utilization of subassembly batch record, SAN 8004, 8th Purified Collagen Cake, for formulation in SAN 8005, 3.5% Atelocollagen with 0.3% Lidocaine, 20cc Syringe, on an as needed basis only.