PMA P140029S047

Device: Restlyane® Refyne Injectable Gel
Applicant: Q-Med AB
PMA number: P140029
Supplement: S047
Product code: LMH
Decision date: 2022-12-23
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for revisions to the clinician labeling and patient labeling of Restylane® Refyne Injectable Gel as a result of postmarket surveillance data.

Current openFDA PMA Record#

Device: Restlyane® Refyne Injectable Gel
Applicant: Q-Med AB
PMA number: P140029
Supplement: S047
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2022-12-23
Decision code: APPR
Date received: 2022-11-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revisions to the clinician labeling and patient labeling of Restylane® Refyne Injectable Gel as a result of postmarket surveillance data.