PMA P110033S006

Device
JUVEDERM VOLUMA XC
Applicant
Allergan
PMA number
P110033
Supplement
S006
Product code
LMH
Decision date
2014-04-28
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
REMOVAL OF TWO IN-PROCESS CONTROL TESTS USED DURING THE MANUFACTURE OF JUVÉDERM VOLUMA XC.

Current openFDA PMA Record#

Device
JUVEDERM VOLUMA XC
Applicant
Allergan
PMA number
P110033
Supplement
S006
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2014-04-28
Decision code
OK30
Date received
2014-03-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVAL OF TWO IN-PROCESS CONTROL TESTS USED DURING THE MANUFACTURE OF JUVÉDERM VOLUMA XC.