|
Device | Restylane, Restylane Lyft with Lidocaine, Restylane Silk, Restylane-L, Perlane |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S123 |
Date Received | 06/07/2021 |
Decision Date | 11/16/2021 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to add a new external sterility testing laboratory for end-product test before product release. |