|
Device | Restylane Injectable Gels |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S131 |
Date Received | 04/04/2022 |
Decision Date | 07/20/2022 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for alternative plunger rod and finger grip to be used with the approved Beckton Dickinson syringe system. |