|
Device | Restylane Lyft with Lidocaine |
Generic Name | Implant, dermal, for aesthetic use in the hands |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S099 |
Date Received | 08/29/2017 |
Decision Date | 05/18/2018 |
Product Codes |
LMH PKY |
Docket Number | 18M-1970 |
Notice Date | 05/22/2018 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT02650921
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the Restylane Lyft with Lidocaine for expanding the indications to include injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21 |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |