FDA.reportPublic FDA data

PMA P140029S024

Device
Restylane Refyne, Restylane Defyne Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S024
Product code
LMH
Decision date
2020-03-19
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Revision of the criteria for the visual inspection of filled and sterilized syringes performed during manufacturing of Restylane Refyne and Restylane Defyne.

Current openFDA PMA Record#

Device
Restylane Refyne, Restylane Defyne Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S024
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-03-19
Decision code
OK30
Date received
2020-02-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Revision of the criteria for the visual inspection of filled and sterilized syringes performed during manufacturing of Restylane Refyne and Restylane Defyne.