PMA P110033S028

Device
Voluma XC, Vollure XC, Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S028
Product code
LMH
Decision date
2017-08-25
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for an additional syringe assembly and packaging line.

Current openFDA PMA Record#

Device
Voluma XC, Vollure XC, Volbella XC
Applicant
Allergan
PMA number
P110033
Supplement
S028
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2017-08-25
Decision code
APPR
Date received
2017-03-20
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for an additional syringe assembly and packaging line.