|
Device | Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB Seminariegatan 21 Uppsala S-752-7522 |
PMA Number | P140029 |
Supplement Number | S028 |
Date Received | 07/29/2020 |
Decision Date | 08/28/2020 |
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 Change the sterilization validation approach to the overkill method/full cycle approach defined in ISO 17665-1:2006 Annex D4. |