FDA.reportPublic FDA data

PMA P140029S034

Device
Restylane Refyne, Restylane Defyne, and Restylane Kysse
Applicant
Q-Med AB
PMA number
P140029
Supplement
S034
Product code
LMH
Decision date
2020-11-06
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane Refyne, Restylane Defyne, and Restylane Kysse.

Current openFDA PMA Record#

Device
Restylane Refyne, Restylane Defyne, and Restylane Kysse
Applicant
Q-Med AB
PMA number
P140029
Supplement
S034
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-11-06
Decision code
OK30
Date received
2020-10-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the distribution systems for Water for Injection (WFI) and changes to producer and distribution system of compressed air in Line 1 (L1) at Q-Med ABUppsala used for the manufacture of Restylane Refyne, Restylane Defyne, and Restylane Kysse.