PMA P140029S056

Device: Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour
Applicant: Q-Med AB
PMA number: P140029
Supplement: S056
Product code: LMH
Decision date: 2026-04-14
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for extension of shelf life for the raw material sodium hyaluronate used in the manufacturing of Restylane Refyne, Restylane Defyne, Restylane Kysse and Restylane Contour

Current openFDA PMA Record#

Device: Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour
Applicant: Q-Med AB
PMA number: P140029
Supplement: S056
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-04-14
Decision code: OK30
Date received: 2026-03-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for extension of shelf life for the raw material sodium hyaluronate used in the manufacturing of Restylane Refyne, Restylane Defyne, Restylane Kysse and Restylane Contour