PMA P140029S058

Device: Restylane® Contour
Applicant: Q-Med AB
PMA number: P140029
Supplement: S058
Product code: LMH
Decision date: 2026-09-18
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: approval for updated device labeling, including the addition of a statement regarding how the Restylane Contour is only for distribution to providers that have taken and successfully completed device-specific use training program when used for the correction of temple hollowing in patients over the age of 21.

Current openFDA PMA Record#

Device: Restylane® Contour
Applicant: Q-Med AB
PMA number: P140029
Supplement: S058
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-09-18
Decision code: APPR
Date received: 2026-05-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for updated device labeling, including the addition of a statement regarding how the Restylane Contour is only for distribution to providers that have taken and successfully completed device-specific use training program when used for the correction of temple hollowing in patients over the age of 21.