|
Device | Restylane® Injectable Gel |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S128 |
Date Received | 11/15/2021 |
Decision Date | 12/09/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Addition of a new supplier for ready-to-use solutions used in the manufacturing of Restylane, Restylane-L, Restylane Lyft with Lidocaine, Perlane, and Restylane Silk. |