PMA P040024S131

Device
Restylane Injectable Gels
Applicant
Q-Med AB
PMA number
P040024
Supplement
S131
Product code
LMH
Decision date
2022-07-20
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for alternative plunger rod and finger grip to be used with the approved Beckton Dickinson syringe system.

Current openFDA PMA Record#

Device
Restylane Injectable Gels
Applicant
Q-Med AB
PMA number
P040024
Supplement
S131
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2022-07-20
Decision code
APPR
Date received
2022-04-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for alternative plunger rod and finger grip to be used with the approved Beckton Dickinson syringe system.