PMA P110033S015

Device
JUVEDERM VOLUMA XC
Applicant
Allergan
PMA number
P110033
Supplement
S015
Product code
LMH
Decision date
2015-10-06
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL FOR AN IMPROVEMENT TO THE METHOD USED TO MEASURE HA CONTENT OF FINAL JUVÉDERM AND VOLUMA XC PRODUCTS DURING BATCH RELEASE.

Current openFDA PMA Record#

Device
JUVEDERM VOLUMA XC
Applicant
Allergan
PMA number
P110033
Supplement
S015
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2015-10-06
Decision code
APPR
Date received
2015-06-10
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR AN IMPROVEMENT TO THE METHOD USED TO MEASURE HA CONTENT OF FINAL JUVÉDERM AND VOLUMA XC PRODUCTS DURING BATCH RELEASE.