FDA.reportPublic FDA data

PMA P140029S031

Device
Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels
Applicant
Q-Med AB
Product code
LMH
Decision date
2020-12-04
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval of changes to the Line 3 cleanrooms 9:169, 9:170, 9:177 and 9:190 in Facility 2, Building 9 at Q-Med ABs site located at Seminariegatan 21, SE-752 58 Uppsala, Sweden, used for the manufacturing of Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.

Current openFDA PMA Record#

Device
Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S031
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-12-04
Decision code
APPR
Date received
2020-09-14
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval of changes to the Line 3 cleanrooms 9:169, 9:170, 9:177 and 9:190 in Facility 2, Building 9 at Q-Med ABs site located at Seminariegatan 21, SE-752 58 Uppsala, Sweden, used for the manufacturing of Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels.