|
Device | RESTYLANE® Injectable Gels |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S134 |
Date Received | 09/07/2022 |
Decision Date | 09/30/2022 |
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 | No |
Approval Order Statement Add a permanent transverse wall between cleanrooms 9:175 and 9:176 in manufacturing L3 for Restylane®, Restylane®-L, Restylane® Lyft with Lidocaine, Perlane® and Restylane® Silk production. |