FDA.reportPublic FDA data

PMA P040024S101

Device
Restylane Lyft with Lidocaine Cannula Injection
Applicant
Q-Med AB
PMA number
P040024
Supplement
S101
Product code
LMH
Decision date
2018-11-02
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for the use of a small bore, blunt tip cannula with Restylane Lyft with Lidocaine for cheek augmentation and the correction of age related midface contour deficiencies in patients over the age of 21.

Current openFDA PMA Record#

Device
Restylane Lyft with Lidocaine Cannula Injection
Applicant
Q-Med AB
PMA number
P040024
Supplement
S101
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2018-11-02
Decision code
APPR
Date received
2018-04-20
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the use of a small bore, blunt tip cannula with Restylane Lyft with Lidocaine for cheek augmentation and the correction of age related midface contour deficiencies in patients over the age of 21.