PMA P050047S045

Device
JUVEDERM HYALURONATE GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S045
Product code
LMH
Decision date
2015-03-04
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
SCALE-UP OF A GEL COMPOUNDING LINE IN THE JUVEDERM MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
JUVEDERM HYALURONATE GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S045
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2015-03-04
Decision code
OK30
Date received
2015-02-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
SCALE-UP OF A GEL COMPOUNDING LINE IN THE JUVEDERM MANUFACTURING PROCESS.