|
Device | Restylane Lyft with Lidocaine Cannula Injection |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S101 |
Date Received | 04/20/2018 |
Decision Date | 11/02/2018 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT03160716
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |