PMA P050047S032

Device
JUVEDERM HYALURONATE GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S032
Product code
LMH
Decision date
2013-09-06
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
CHANGE THE HYALURONIC ACID (HA) CONCENTRATION DURING A MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
JUVEDERM HYALURONATE GEL IMPLANTS
Applicant
Allergan
PMA number
P050047
Supplement
S032
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2013-09-06
Decision code
OK30
Date received
2013-08-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE THE HYALURONIC ACID (HA) CONCENTRATION DURING A MANUFACTURING PROCESS.