FDA.reportPublic FDA data

PMA P040024S116

Device
RESTYLANE Injectable Gels
Applicant
Q-Med AB
PMA number
P040024
Supplement
S116
Product code
LMH
Decision date
2019-10-08
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for reclassification of Impurity C in Lidocaine (HCl) of RESTYLANE Injectable Gels from a Specified Unidentified Impurity to an Unspecified Unidentified Impurity.

Current openFDA PMA Record#

Device
RESTYLANE Injectable Gels
Applicant
Q-Med AB
PMA number
P040024
Supplement
S116
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-10-08
Decision code
APPR
Date received
2019-07-10
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for reclassification of Impurity C in Lidocaine (HCl) of RESTYLANE Injectable Gels from a Specified Unidentified Impurity to an Unspecified Unidentified Impurity.