PMA P040024S146

Device
Restylane® Lyft with Lidocaine
Applicant
Q-Med AB
PMA number
P040024
Supplement
S146
Product code
LMH
Decision date
2025-12-23
Classification
General, Plastic Surgery
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for the postapproval study (PAS) protocol submitted to comply with the conditions of approval outlined in the approval order for P040024/S142.

Current openFDA PMA Record#

Device
Restylane® Lyft with Lidocaine
Applicant
Q-Med AB
PMA number
P040024
Supplement
S146
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2025-12-23
Decision code
APPR
Date received
2025-12-02
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for the postapproval study (PAS) protocol submitted to comply with the conditions of approval outlined in the approval order for P040024/S142.