PMA P050047S031

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S031
Product code: LMH
Decision date: 2013-11-26
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR CHANGE TO THE CONCENTRATION OF THE LIDOCAINE SOLUTION INTRODUCED TO THE GEL DURING THE HOMOGENIZATION STEP FROM 50% W/W TO 30% W/V LIDOCAINE HYDROCHLORIDE AND A REVALIDATION, BY WEIGHT, THE AMOUNT OF GEL THAT CAN BE MIXED DURING THE HOMOGENIZATION STEP OF THE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: JUVEDERM HYALURONATE GEL IMPLANTS
Applicant: Allergan
PMA number: P050047
Supplement: S031
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2013-11-26
Decision code: APPR
Date received: 2013-08-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGE TO THE CONCENTRATION OF THE LIDOCAINE SOLUTION INTRODUCED TO THE GEL DURING THE HOMOGENIZATION STEP FROM 50% W/W TO 30% W/V LIDOCAINE HYDROCHLORIDE AND A REVALIDATION, BY WEIGHT, THE AMOUNT OF GEL THAT CAN BE MIXED DURING THE HOMOGENIZATION STEP OF THE MANUFACTURING PROCESS.