|
Device | Restylane, Perlane, Restylane Lyft (formerly Perlane-L), Restylane Silk |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S093 |
Date Received | 10/06/2016 |
Decision Date | 11/01/2016 |
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 sterilization site for plungers used with Restylane-L 2 mL and Perlane-L 2 mL. |