FDA.reportPublic FDA data

PMA P140029S026

Device
Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S026
Product code
LMH
Decision date
2020-07-01
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Change from manual handling of syringes during visual inspection to semiautomatic handling of syringes for Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.

Current openFDA PMA Record#

Device
Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S026
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-07-01
Decision code
OK30
Date received
2020-06-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change from manual handling of syringes during visual inspection to semiautomatic handling of syringes for Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.