PMA P020012S035

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S035
Product code
LMH
Decision date
2019-10-25
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Alternative Quality Control test method for PMMA microspheres.

Current openFDA PMA Record#

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S035
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-10-25
Decision code
OK30
Date received
2019-09-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternative Quality Control test method for PMMA microspheres.