FDA.reportPublic FDA data

PMA P140029S025

Device
Restylane Refyne, Restylane Defyne Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S025
Product code
LMH
Decision date
2020-05-21
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for revisions to the clinician and patient labeling of Restylane Defyne and Restylane Refyne to include updated safety information based upon post marketing surveillance data.

Current openFDA PMA Record#

Device
Restylane Refyne, Restylane Defyne Injectable Gels
Applicant
Q-Med AB
PMA number
P140029
Supplement
S025
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2020-05-21
Decision code
APPR
Date received
2020-04-21
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the clinician and patient labeling of Restylane Defyne and Restylane Refyne to include updated safety information based upon post marketing surveillance data.