PMA P040024S127

Device: Restylane-L; Restylane Lyft; Restylane Silk
Applicant: Q-Med AB
Product code: LMH
Decision date: 2022-10-25
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for the transfer of the processing (washing and release) of plungers used in the manufacturing of Restylane-L®, Restylane Lyft® with Lidocaine, and Restylane® Silk to a new site.

Current openFDA PMA Record#

Device: Restylane-L; Restylane Lyft; Restylane Silk
Applicant: Q-Med AB
PMA number: P040024
Supplement: S127
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2022-10-25
Decision code: APPR
Date received: 2021-09-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the transfer of the processing (washing and release) of plungers used in the manufacturing of Restylane-L®, Restylane Lyft® with Lidocaine, and Restylane® Silk to a new site.